Dynamic support apparatus and system

ABSTRACT

A dynamic support system includes a control system for controlling inflation and deflation of at least one actuator having an inlet connectable to the a control unit of the dynamic support system. The control unit may be in communication with a sensor and may control inflation and deflation of the at least one actuator in response to information provided by the sensor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/622,102, filed Feb. 13, 2015, which is a continuation of U.S. patentapplication Ser. No. 13/088,035, filed Apr. 15, 2011, which claimspriority to U.S. Provisional Patent Application Ser. No. 61/376,924,filed Aug. 25, 2010, and which is a continuation-in-part of U.S. patentapplication Ser. No. 12/706,340, filed Feb. 16, 2010, now U.S. Pat. No.8,074,559, which claims priority to U.S. Provisional Patent ApplicationSer. No. 61/168,793, filed Apr. 13, 2009, and which is acontinuation-in-part of U.S. patent application Ser. No. 12/026,971,filed Feb. 6, 2008, now U.S. Pat. No. 8,870,970, which claims priorityfrom U.S. Provisional Patent Application Ser. No. 60/899,835, filed Feb.6, 2007, each of which applications is hereby incorporated by referenceherein in its entirety.

STATEMENT OF GOVERNMENT INTEREST

This invention was made with Government support under Contract NumberW911NF-09-C-0035 awarded by the U.S. Army RDECOM ACQ CTR. The Governmenthas certain rights in the invention.

TECHNICAL FIELD

The present invention relates to support apparatuses and morespecifically to dynamic support apparatuses.

BACKGROUND INFORMATION

This support apparatus may be used for upper-limb and lower-limbprosthetic devices, or any device with interaction with the body, butfor exemplary purposes, the present apparatus will be described in thecontext of prostheses for upper-limb amputees.

Accordingly, there is a need for a dynamic support apparatus thataccommodates users' needs in the interaction with the user. A devicethat can, in addition to other features, include changing geometry inresponse to residuum morphing or external mechanical prosthesis loadingto maintain a secure, comfortable fit with the user's body, and/ormaintain a comfortable temperature and moisture environment between thesupport apparatus and the user's body is desired.

SUMMARY OF THE INVENTION

In accordance with one aspect of the present invention, a control unitfor a dynamic support apparatus having at least one actuator includes apump connected to the at least one actuator for causing actuationthereof. The control unit also includes a sensor detecting a pressure ofthe at least one actuator and a control system for controlling the pumpto actuate the at least one actuator at least in response to thepressure detected by the sensor.

In accordance with another aspect of the invention, the control unitincludes a detachable manifold fluidly coupling the at least oneactuator to the pump to control the distribution of air to the at leastone actuator. In some embodiments, the detachable manifold may beattached to the control unit using magnetic force. The control unit mayalso include at least one valve allowing the control system to controlairflow through the detachable manifold.

In accordance with another aspect of the present invention, at least onesensor provides information on the stability and fit of the supportapparatus to the control system. In accordance with a further aspect ofthe present invention, the at least one sensor is a pressure transducer.In accordance with another aspect of the present invention, the controlsystem maintains a constant pressure measured by the pressuretransducer. In accordance with another aspect of the present invention,the control system increases the pressure of at least one actuator ifthe pressure detected by the sensor drops below a current pressuresetpoint by more than a pre-determined error threshold.

In accordance with a further aspect of the present invention, thecontrol system actuates a change in geometry of the dynamic interfacebased on the information provided by the at least one sensor. In oneaspect of the present invention, the control system evaluates a useractivity level based at least on the information provided by the atleast one sensor. In another aspect of the present invention, theevaluation of the user activity level is also based on a pressurevariability and a duration of the pressure variability. According toanother aspect of the present invention, the control system increasesthe pressure of at least one actuator if a high activity threshold isexceeded and decreases the pressure of at least one actuator if a lowactivity threshold is exceeded.

In yet another aspect of the present invention, the control systemevaluates whether a safety threshold has been exceeded based at least onthe information provided by the at least one sensor. In another aspectof the present invention, the evaluation of whether the safety thresholdhas been exceeded is also based on a temperature. In one aspect of thepresent invention, the control system enters an auto-relief mode if thesafety threshold has been exceeded.

In another aspect of the present invention, a method for control of atleast one actuator of a dynamic support apparatus includes monitoring apressure of the at least one actuator and altering the pressure of theat least one actuator based at least in part on the monitored pressure.According to some aspects of the present invention, the method includesincreasing the pressure of the at least one actuator if the monitoredpressure drops below a current pressure setpoint by more than apre-determined error threshold. In another aspect of the presentinvention, the method includes evaluating a user activity level based atleast on the pressure of the at least one actuator. In yet anotheraspect of the present invention, the method includes evaluating whetherthe safety threshold has been exceeded based at least on the pressure ofthe at least one actuator.

These aspects of the invention are not meant to be exclusive and otherfeatures, aspects, and advantages of the present invention will bereadily apparent to those of ordinary skill in the art when read inconjunction with the appended claims and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will bebetter understood by reading the following detailed description, takentogether with the drawings wherein:

FIG. 1 is a perspective view of one embodiment of a dynamic supportapparatus representative of a transhumeral configuration;

FIG. 2 is a top view of the embodiment of the dynamic support apparatusof FIG. 1;

FIG. 3 is an internal view of the embodiment of the dynamic supportapparatus of FIGS. 1 and 2;

FIG. 4 is a cross-sectional view of one embodiment of an actuator of thedynamic support apparatus in an inactuated state;

FIG. 5 is a cross-sectional view of the actuator of FIG. 4 of thedynamic support apparatus in an actuated state;

FIG. 6 is a cross-sectional view of another embodiment of an actuator ofthe dynamic support apparatus in an inactuated state;

FIG. 7 is a cross-sectional view of the actuator of FIG. 6 of thedynamic support apparatus in an actuated state;

FIG. 8 is a perspective view showing the top and bottom of oneembodiment of an actuator of the dynamic support apparatus;

FIG. 9 is a perspective view showing the top and bottom of anotherembodiment of an actuator of the dynamic support apparatus;

FIG. 10 is a perspective view of a dynamic support apparatus with theactuators of FIG. 9 installed;

FIG. 11 is an illustration of a technique for fabricating a portion of adynamic interface according to an embodiment of the present invention;

FIG. 12A is a top view of one embodiment of the dynamic interface of adynamic support apparatus;

FIG. 12B is a side view of the dynamic interface of FIG. 12A withrespect to the frame of an embodiment of a dynamic interface;

FIG. 13 is a bottom view of one embodiment of the dynamic interface of adynamic support apparatus;

FIG. 14 is an exploded view of the dynamic interface of FIG. 13;

FIG. 15 is a perspective view of one embodiment of an actuator andcontrol system of a dynamic support apparatus;

FIG. 16 is one embodiment of a manual control system of a dynamicsupport apparatus;

FIG. 17 is one embodiment of a manual control system of a dynamicsupport apparatus;

FIG. 18A is an internal perspective view of one embodiment of a controlunit of a dynamic support apparatus;

FIG. 18B is an exploded view of the control unit of FIG. 18A;

FIG. 19A is a top perspective view of an embodiment of a control unitfor a dynamic support apparatus;

FIG. 19B is a partially exploded view of the control unit of FIG. 19A;

FIG. 19C is an exploded view of an interior of the control unit of FIG.19B;

FIG. 19D is a top perspective view of the control unit of FIG. 19A witha detachable manifold removed therefrom;

FIG. 20 is a cross-sectional view of one embodiment of an actuator andcontrol system;

FIG. 21 is a cross-sectional view of one embodiment of an actuator andcontrol system;

FIG. 22 is a perspective view of one embodiment of a dynamic supportapparatus representative of a shoulder disarticulated configuration;

FIG. 23 is a cross-sectional view of an un-actuated actuator and sensorunit;

FIG. 24 is the cross-sectional view of FIG. 23 with the actuatoractuated;

FIG. 25 is a cross-sectional view of one embodiment of a temperaturecontrol system of a dynamic support apparatus;

FIG. 26 is a front view of an alternative embodiment of a dynamicsupport apparatus as it is worn around the body;

FIG. 27 is a side view of the dynamic support apparatus of FIG. 26;

FIG. 28 is a structural view of the dynamic support apparatus of FIGS.26 and 27;

FIG. 29 is a perspective view of one embodiment of an un-actuated activestrap of a dynamic support apparatus;

FIG. 30 is a cross-sectional view of the active strap of FIG. 29;

FIG. 31 is a perspective view of the active strap of FIGS. 29 and 30when actuated;

FIG. 32 is a cross sectional view of the actuated active strap of FIG.31;

FIG. 33 is a perspective view of one embodiment of an active strap andcontrol system of a dynamic support apparatus;

FIG. 34 is a perspective view of an alternative embodiment of an activestrap and control system of a dynamic support apparatus;

FIG. 35 is a front perspective view of one embodiment of a dynamicsupport apparatus showing a prosthetic interface;

FIG. 36 is a rear perspective view of the dynamic support apparatus ofFIG. 35;

FIG. 37 is an illustration of a portion of one technique for fabricatingand embodiment of a dynamic interface for a dynamic support apparatus;

FIG. 38 is an illustration of a portion of the technique for fabricatingand embodiment of a dynamic interface for a dynamic support apparatus;

FIG. 39 is a front view of the dynamic interface fabricated from thetechnique of FIGS. 37 and 38;

FIG. 40 is a front perspective view of the dynamic support apparatus ofFIGS. 37-39;

FIG. 41 is a rear perspective view of the dynamic support apparatus ofFIGS. 37-39;

FIG. 42 is a front view of an alternative embodiment of a dynamicinterface fabricated from the technique of FIGS. 37 and 38;

FIG. 43 is a front assembled view of the dynamic interface of FIG. 42;

FIG. 44 is a front perspective view of the dynamic support apparatus ofFIG. 43 as worn by a patient;

FIG. 45 is a rear perspective view of the dynamic support apparatus ofFIG. 43 as worn by a patient;

FIG. 46 is a top view of an alternative embodiment of a dynamic supportapparatus;

FIG. 47 is the dynamic support apparatus of FIG. 46 when partiallyopened;

FIG. 48 is a perspective view of the dynamic support apparatus of FIG.46;

FIG. 49 is a side view of the dynamic support apparatus of FIG. 46 whencompletely opened;

FIG. 50 is an illustrative view of a strap according to one embodiment;

FIG. 51 is an illustrative view of a strap according to one embodiment;

FIG. 52 is a schematic diagram of the prosthetic support apparatusaccording to another embodiment of the present invention;

FIG. 53 is a perspective view of the prosthetic support apparatus ofFIG. 52;

FIG. 54 is a side view of a laterally stabilized bladder in an actuatedstate according to an embodiment of the present invention;

FIG. 55 is a front view of the laterally stabilized bladder of FIG. 54;

FIG. 56 is a side view of the laterally stabilized bladder of FIG. 54 inan inactuated state;

FIG. 57 is a perspective view of an embodiment of a prosthetic supportapparatus including the laterally stabilized bladder of FIG. 54;

FIG. 58 is a cross-sectional view of the prosthetic support apparatus ofFIG. 57 in an inactuated state with a residuum inserted therein;

FIG. 59 is a cross-sectional view of the prosthetic support apparatus ofFIG. 58 in an actuated state;

FIG. 60 is a side view of the laterally stabilized bladder of FIG. 56with a resilient member;

FIG. 61 is a perspective view of a control system according to anotherembodiment of the present invention;

FIG. 62 is a perspective view of a prosthetic support apparatusrepresentative of a transradial system according to yet anotherembodiment of the present invention;

FIG. 63 is a schematic diagram of a dynamic support system according toan embodiment of the present invention;

FIG. 64A is a schematic diagram of a dynamic support system togetherwith a dynamic controller apparatus according to one embodiment;

FIG. 64B is a schematic diagram of a dynamic support system according toone embodiment;

FIG. 65 is a flow diagram of one embodiment of the methods for donningthe dynamic support apparatus;

FIG. 66 is a flow diagram of one embodiment of the methods formaintaining the baseline pressure of the one or more actuators;

FIG. 67 is a schematic view of an embodiment for a leak detectioncontrol mode according to the present invention;

FIG. 68 is a schematic view of another embodiment for the leak detectionmode according to the present invention;

FIG. 69 is a flow diagram of one embodiment of the methods forincreasing the pressure of the one or more actuators in preparation forhigh-intensity activity;

FIG. 70 is a flow diagram of one embodiment of the methods fordecreasing the pressure of the one or more actuators in preparation forlow-intensity activity;

FIG. 71 is a flow diagram of one embodiment of a method for auto-reliefaccording to the present invention; and

FIG. 72 is an embodiment of a donning stand according to another aspectof the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

For exemplary purposes, the support apparatus will be described in theembodiment of a support apparatus 10 for an upper-limb trans-humeral(TH) prosthesis, as seen in FIG. 1, such as the various prosthetic armsdescribed in U.S. patent application Ser. No. 12/027,141, filed Feb. 6,2008, U.S. patent application Ser. No. 12/706,609, filed Feb. 16, 2010,and U.S. patent application Ser. No. 13/088,063, filed Apr. 15, 2011,each of which is hereby incorporated by reference in its entirety.

Referring to FIG. 2, the support apparatus 10, which is utilized toremovably adhere a prosthesis 11, shown in FIG. 63, to an upper-limbresiduum 12 (FIG. 1), includes a frame 14, a dynamic interface 16, acontrol system 18, and a temperature control mechanism 19. The frame isgenerally rigid and may be made of high tech composite material such ascarbon fiber.

In one embodiment, the frame 14 may be open and have a plurality ofapertures 20. The structural members of the frame of this embodiment maybe strategically placed to maximize the openness of the apparatus.Additionally, the plurality of apertures 20 may be the temperaturecontrol mechanism or function as a part of the temperature controlmechanism.

The dynamic interface 16 is disposed on a top surface 22 of the frameclosest to the upper-limb residuum 12. The dynamic interface 16 includesone or more actuators 24 of various shapes and sizes that can bepositioned either longitudinally and/or circumferentially along theframe 14. The actuators 24 are capable of changing their geometry andvolume to secure the support apparatus 10 to the residuum 12, shown inFIG. 1, and to account for morphing in the residuum 12.

As discussed above, the support apparatus 10 includes apertures 20 toaddress both structural and temperature concerns. In addition, theapertures 20 may be designed to provide relief to the residuum 12, shownin FIG. 1, when the support apparatus 10 is secured thereonto. Forinstance, the apertures 20 may provide space to allow the soft tissue ofthe residuum 12, shown in FIG. 1, to move away from the actuators 24,thereby minimizing the amount of soft tissue between the load bearingsurfaces of the support apparatus 10, i.e. the actuators 24, and thebone within the residuum 12, shown in FIG. 1. Thus, the apertures 20allow the soft tissue of the residuum 12 to escape the areas of contactwith the actuators 24, thereby providing relief to the user and allowingthe actuators 24 to engage to bone within the residuum 12, shown in FIG.1.

Although described as apertures 20, in some embodiments, the supportapparatus 10 may additionally include at least one hollow cavity toprovide another means for soft tissue escape. Thus, as the actuators 24change their geometry to secure the support apparatus 10 to the residuum12, shown in FIG. 1, the soft tissue may be displaced into the hollowcavities during actuation to provide relief to the user.

Referring to FIG. 3, the actuators 24 may be bladders 28 filled withair, gas or incompressible liquid, electroactive polymers (EAPs), orother types of actuators capable of changing their geometry. The dynamicinterface also includes one or more connectors 26 that connect theactuator(s) 24 to the control system 18. The connector(s) may be fluidpaths, tubes, wires, or other similar channels.

Referring to FIGS. 4 and 5, in an embodiment having bladders 28 foractuators 24 and fluid path connectors 30 for connectors 26, the bladder28 will change geometry from an inactuated position shown in FIG. 4 tothe actuated position shown in FIG. 5 when filled with air. Although thebladder 28 is shown with a substantially uniform cross section in FIGS.4 and 5, the same functionality may be obtained from the bladder 1028having a non-uniform cross-section shown inactuated in FIG. 6 andactuated in FIG. 7, wherein the like numerals represent the likeelements.

Referring to FIG. 8, in a further embodiment, the bladders 2028 may havebladder inlets 2032 to facilitate the connection of the fluid pathconnectors 30, shown in FIGS. 4 and 5. The bladder inlets 2032 may belocated at any position on a periphery 2033 of each bladder 2028 toaccommodate the desired fluid path connector routing configuration.Referring to FIG. 9, an alternative embodiment positions the bladderinlet 3032 on a body 3035 of the bladder 3028. In this embodiment, asseen in FIG. 10, the bladder inlet 3032 may pass through the frame 3014to facilitate connection to the fluid path connectors 3030.

In one embodiment, the frame has an outer shell and an inner shell.Here, the dynamic interface may be disposed between the outer shell andthe inner shell. The inner shell may also have apertures to dictate theshape the actuator(s). For example, if the actuator(s) are bladders, theinner shell apertures would dictate the shape of the bladder as it isinflated.

Referring to FIG. 11, in some embodiments the frame 14 may be formedaccording to a casting process using one or more casting blanks 15 toprovide bladder accommodations 17 within the frame 14 that have planarsurfaces upon which the bladders 28, shown in FIG. 3, may sit. Theplanar surfaces of these bladder accommodations 17 advantageouslyprevent the bladders 28, shown in FIG. 3, from un-adhering thereto,which is more likely with curved surfaces. The one or more castingblanks 15 are formed to have a size and shape that is substantially thesame as the bladders 28, shown in FIG. 3, and any fastening mechanismthat will fasten the bladders 28, shown in FIG. 3, to the frame 14, suchas Velcro and glue. Additionally, each casting blank 15 has a taperedhole 21 formed therein to facilitate the formation of holes 23 forallowing the bladders 28, shown in FIG. 3, to be connected to connectors26, shown in FIG. 3.

During the casting process, a prosthesist or clinician forming the frame14 covers the portion of the residuum 12 that is being cast with one ormore plaster wraps 25. The prosthesist presses the one or more castingblanks 15 into the outer surface of the plaster wraps 25 at locationswhere bladders 28, shown in FIG. 3, are to contact the residuum 12within the fully formed dynamic support apparatus 10, shown in FIG. 3.The prosthesist allows the plaster wraps 25 to cure with the castingblanks 15 pressed therein such that bladder impressions 27 are formedwithin the fully cured plaster wraps 25. While allowing the plasterwraps 25 to cure, the prosthesist preferably ensures that the castingblanks 15 remain parallel to the bone within the residuum 12. The curedplaster wraps 25 may then be filled to form a plaster positive 31, whichwill also have the bladder impressions 29 formed therein. The castingblanks 15 may then be secured to the plaster positive 31 and the frame14 may be cast therearound to form the bladder accommodates 17 on theinner surface of the frame 14. In some embodiments, the casting blanks15 may include one or more tack holes for allowing one or more tacks topass therethrough to secure to the casting blanks 15 to the plasterpositive 31. As discussed above, the tapered holes 21 of the castingblanks 15 form dimpled impressions in the outer surface of the frame 14,thereby advantageously locating the drilling locations for the holes 23.

The casting blanks 15 and the casting process discussed in connectionwith FIG. 11, advantageously allows for the formation of bladderaccommodations 17 that are straight and parallel to the bone within theresiduum 12, rather than following the curved outer surface of theresiduum 12. This allows the bladders 28, shown in FIG. 3, positionedwithin the bladder accommodations 17 to better engage the residuum 12,and the bone therein, to provide a more secure and better load bearingfit for the dynamic support apparatus 10, shown in FIG. 3, as comparedto a support formed with the curved outer surface of the residuum 12,which would tend to push the residuum 12 out of the socket whenactuated.

In another alternative embodiment, referring to FIGS. 12A and 12B, thedynamic interface 4016 is a single integrated layer 4034 disposed on thetop surface 4022 of the frame 4014. For example, in an embodiment havingbladders 4028 with fluid path connectors 4030, the bladders 4028 andfluid paths connectors 4030 are embedded into a single layer of materialthat is placed on top of the frame 4014. The single integrated layer4034 may be made of any material that allows for morphable chambers thatcan house or act as actuators of variable geometry. Such material may besilicone or rapid prototype molding material covered with a layer ofsilicone. The single integrated layer 4034 may also have nodules 4036 toattach to the frame 4014 having corresponding apertures 4037 for thenodules 4036. In some embodiments, the nodules 4036 are protrusions. Thenodules 4036 do not have to be round bumps as depicted in one embodimentof the apparatus.

Referring to FIG. 13, the bladders 4028 and fluid path connectors 4030may be molded as a part of the single integrated layer 4034, such thatthe layer itself contains internal paths and compartments that serve asthe fluid path connectors 4030 and bladders 4028, respectively. Themolded single integrated layer 4034 may also have nodules 4036 to attachto a frame having corresponding apertures 4037. As seen in FIG. 14, thesingle integrated layer 4034 may be constructed by molding an actuationlayer 4038, containing the necessary bladders 4028 and fluid pathconnectors 4030, and a connection layer 4040, containing nodules 4036for attaching the single integrated layer 4034 to the frame. Theactuation layer 4038 and the connection layer 4040 can then be bondedtogether to form the single integrated layer 4034, as seen in FIG. 13.The molded single integrated layer 4034 may be fabricated from anymaterial that allows morphable chambers that can act as actuators ofvariable geometry. Such material may be silicone or rapid prototypemolding material covered in a layer of silicone. Additionally, bladders,such as the bladders 2028, shown in FIG. 8, or the bladders 3028, shownin FIG. 9, with their unique characteristics, may also be embedded inthe molded single integration layer 4034, which may provide the dynamicinterface 4016 with characteristics of both the bladders and the moldedsingle integration layer 4034, for example, to increase actuation whileincreasing stability.

The dynamic interface 16 allows the support apparatus 10 to morph andadapt to the function of the residuum 12. For example, in an embodimenthaving actuators 24 that are bladders 28 filled with gas, when theresiduum 12 morphs, possibly due to tissue volume variation or loading,the bladders 28 either inflate or deflate to adjust to the residuum 12morphing and to maintain a secure and comfortable fit on the residuum12.

The control system 18 controls the changing geometry of the actuators24. The control system 18 may be hydraulic, pneumatic,electromechanical, mechanical, or any other actuator type mechanism thatallows the actuators 24 to change geometry. In our exemplary embodiment,the bladders 28 are controlled by a pneumatic system and connected tothe system by the fluid paths connectors 30.

Referring now to FIG. 15, one embodiment of the control system 18 isshown as a manual system with a pressure bulb 42 that is connected tothe bladder 28 by one or more fluid path connectors 30 and one or morevalves 43. When the user begins to feel instability with the fit of thesupport apparatus 10, the user squeezes the pressure bulb 42 to increasethe air or liquid pressure in the bladder 28, thus adjusting the fit ofthe support apparatus 10 to the user's liking. The user may alsodecrease the pressure in the bladder 28 by opening the valve 43. If morethan one bladder 28 is used, the user may be able to adjust the pressurein each individual bladder 28.

Still referring to FIG. 15, in this embodiment, the bladder 28 is laserwelded. By laser welding a thin sheet 41 of bladder material to asubstantially thicker sheet 45 of bladder material or a stable basematerial, such as an injection molded flexible plastic, the actuationcan be isolated to a desired direction. As seen in FIG. 15, the bladder28 deforms in the direction of the thin sheet 41 of material, while theremainder of the bladder 28 remains substantially unchanged.

Referring now to FIG. 16, in an alternative embodiment of the controlsystem 5018, the pressure bulb 5042 is connected to a plurality ofbladders by one or more fluid path connectors 5030 and valves 5043through a manifold 5044. The manifold may have pressure selectors 5046allowing the user to adjust the pressure in the plurality of bladders bydifferent amounts with the pressure bulb 5042. The user may thus presetthe pressure selectors 5046 to provide optimal adjustment of the supportapparatus. Additionally, the pressure selectors 5046 also allow the userto target one or more specific bladder(s) of the plurality of bladders,such that pressure can be adjusted solely in the targeted bladders)while pressure in the rest of the plurality of bladders remainsunchanged. This targeting capability permits pinpoint adjustment basedon localized instability or discomfort.

Referring now to FIG. 17, the control system 5018 includes an electricpump 5048 in place of the pressure bulb 5042 for adjusting the pressurein the plurality of bladders. Pump control 5050 allows the user toeither increase or decrease the pressure in the bladders.

Referring to FIGS. 18A and 18B, an alternate embodiment incorporates theelectric pump 6048, the pump control 6050, one or more valves 6043 andthe manifold 6044 into a control unit 6052. The fluid path connectorsare attached to manifold outlets 6054, allowing adjustment of eachbladder using the pump control 6050. In some embodiments, each manifoldoutlet 6054 is in fluid communication with the manifold 6044 through atleast one valve 6043 such that the user may control inflation anddeflation of each bladder individually through activation of the pump6048 and/or the valves 6043. In some embodiments the manifold 6044, maybe located in an accessible location, such as attached to the user'sbelt, or attached to the support apparatus itself.

Referring now to FIGS. 20 and 21, an alternate embodiment integrateseach bladder 7028 and its control system 7018. In the embodiment shownin FIG. 20, the control system 7018 is a pressure bulb 7042. In theembodiment shown in FIG. 21, the control system 7018 is an electric pump7048. In such an embodiment, the patient would adjust the pressure ofeach bladder 7028 by actuating its integrated control system 7018.

Referring to FIG. 19A-19C, in some embodiments, the control unit 8052includes a housing 8053 having the pump control 8050 integrated therein.Disposed within the housing are the electric pump 8048, shown in FIG.19B, the one or more valves 8043, shown in FIG. 19C and the manifold8044, shown in FIG. 19C, as well as electrical connections, such ascircuit board 8057, shown in FIG. 19B, one or more processors (notshown), a power supply 8059, shown in FIG. 19B, and the like forconnecting the pump control 8050 to the electric pump 8048 and the oneor more valves 8043 to allow the user to control the operation thereof.The pump control 8050 may include one or more user inputs 8055 that mayinclude, for example, buttons, each to activate a particular/specificsupport apparatus control mode, as will be discussed in greater detailbelow. In some embodiments, the one or more user inputs 8055 may includea “function” or “toggle” switch so as to use the same button or userinput 8055 for multiple functionalities. In some embodiments, the powersupply 8059 for the control unit 8052 may advantageously include arechargeable lithium battery.

Referring to FIG. 19D, the control unit 8052 may include a detachablemanifold 8148 to facilitate connection of the connectors 26, shown inFIG. 3, such as flexible tubing, to the control unit 8052. Thedetachable manifold 8148 may include a plurality of interior channels8150 extending therethrough to which the connectors 8026 may be coupled.The detachable manifold 8148 mates with a gasket 8152 of the controlunit 8052 such that the interior channels 8150 align and communicatewith fluid channels 8154 of the control unit 8052. The gasket 8152 maybe a planar gasket that prevents leakage at the interface between thefluid channels 8154 and the interior channels 8150 or may include, invarious embodiments, a sealing element such as a silicone sheet, ano-ring surrounding each fluid channel 8154 or the like. In someembodiments, the detachable manifold 8148 and/or the control unit 8052may include one or more magnets 8156 that align to facilitate theconnection between the detachable manifold 8148 and the control unit8052 and that hold the detachable manifold 8148 in position with thegasket 8152. In some embodiments, only one of the detachable manifold8148 and the control unit 8052 is provided with one or more magnets8156, while the other of the detachable manifold 8148 and the controlunit 8052 is provided with one or more metal features for attracting theone or more magnets 8156. For instance, in an embodiment where thedetachable manifold 8148 includes one or more magnets 8156, the controlunit 8052 may be provided with a metal face plate that forms at least aportion of the gasket 8152 for contacting the detachable manifold 8148.In other embodiments, the detachable manifold 8148 may be attachedthrough other known fastening means such as a latch or the like.Additionally, in some embodiments, the detachable manifold 8148 may beconnected to the control unit 8052 through a hinged connection thatallows the detachable manifold 8148 to pivot relative to the gasket 8152or a partial hinged connection that allows the detachable manifold 8148to pivot relative to the gasket 8152 and to be fully detached from thecontrol unit 8052 if desired. In some embodiments, the detachablemanifold 8148 and the control unit 8052 may include one or morecomplimentary alignment features 8061 to aid with proper alignment ofthe interior channels 8150 and fluid channels 8154 when the detachablemanifold 8148 is connected to the control unit 8052.

The pump 8048, shown in FIG. 19B, is connected to each fluid channel8154 through a valve 8043, shown in FIG. 19C, and through the manifold8044, shown in FIG. 19C, such that the control unit 8052 is able tocontrol the pump 8048, shown in FIG. 19B and one or more valves 8043,shown in FIG. 19C, to supply air to one or more of the fluid channels8154 and, therefore, to the connectors 26, shown in FIG. 3, through theinterior channels 8150 of the detachable manifold 8148. Thus, when thedetachable manifold 8148 is connected to the control unit 8052, thecontrol unit 8052 may supply air to one or more bladders 28, shown inFIG. 3, to control actuation thereof. For example, in some embodiments,the control unit 8052 may control six actuators 24, shown in FIG. 3,however, in other embodiments, the control unit 8052 may control as manyactuators 24, shown in FIG. 3 as desired.

The detachable manifold 8148 may advantageously be detached from thecontrol unit 8052 to quickly deflate all bladders 28, shown in FIG. 3,connected thereto so that the dynamic support apparatus 10, shown inFIG. 3, may be removed from the user. This may be particularlyadvantageous in emergency situations or the like. Additionally, thecontrol unit 8052 may also advantageously be detached from thedetachable manifold 8148 and attached to a test and/or calibration unit(not shown) for the dynamic support apparatus 10, shown in FIG. 3. Thedetachable manifold 8148 may also advantageously allow the control unit8052 to be easily detached from the dynamic support apparatus 10, shownin FIG. 3, for charging of the power supply 8059, shown in FIG. 19B, forexample, on a wireless charging pad or the like. In some embodiments,the detachable manifold 8148 may be integral with a holster, such as abelt holster, for the control unit 8052. Integrating the detachablemanifold 8148 into the holster may advantageously allow the connectors26, shown in FIG. 3, to terminate in the holster, allowing the controlunit 8052 to be attached thereto, making the pneumatic connections inthe process.

In some embodiments, the control unit 8052 includes a detection means(not shown) for alerting the control unit 8052 as to whether or not thedetachable manifold 8148 is attached thereto. For example, the detectionmeans (not shown) may include, but is not limited to, a mechanicalswitch, an electrical circuit that is completed through contact of thedetachable manifold 8148 and the control unit 8052, a Hall effect sensoror the like. In some embodiments, the detection means (not show) mayalso allow the control unit 8052 to automatically detect that it isconnected to the test and/or calibration unit (not shown).

The control unit 8052 may be generally the size of a personal dataassistant or smart phone and, in some embodiments, the control unit 8052may advantageously control more than one dynamic support apparatus 10,shown in FIG. 3. In other embodiments, a user may wear a separatecontrol unit 8052 for each dynamic support apparatus 10, shown in FIG.3. In some embodiments, multiple control units 8052 may be used and maywork cooperatively or independently from a common set of inputs.

The control system 18, shown in FIG. 1, may be an active control systemthat provides real-time adjustments in each actuator 24, shown in FIG.3, to accommodate prosthetic load and user posture and to anticipateuser needs. For example, with the exemplary embodiment having bladders28, shown in FIG. 3, as actuators 24, shown in FIG. 3, the control unit8052 may include an active control system with various control modes foractivating the inflation/deflation of the bladders 28, shown in FIG. 3,as will be discussed in greater detail below. The active control systemmay be in place of, or in addition to, the manual pump control discussedherein. The active control system 18 may have one or more inputmechanisms for gathering readings on the stability and fit of thesupport apparatus 10, shown in FIG. 1, with the residuum 12, shown inFIG. 1.

In some embodiments, the input mechanism includes sensors, such aspressure transducers. The sensors may be placed on the inner shell ofthe frame, on the actuator(s), on the connector(s) connected to theactuator(s), or in any other suitable location, for providinginformation on the stability and fit of the support apparatus, as shouldbe obvious to those skilled in the art. Controlled by a computer orprocessor, the sensor(s) determine the pressure in the actuator(s) and,with the feedback loops, signals are sent to the control unit to eitherincrease or decrease the actuator's pressure, possibly by inflation ordeflation, thereby changing the volume of the actuator to exert theneeded force to maintain the support apparatus's secure fit with theuser's body. The computer or processor for controlling the sensors ispreferably integrated into the control unit 8052 of the control system18, shown in FIG. 1, as discussed above. Referring to FIG. 22, with theexemplary embodiment having bladders 7028 as actuators 7024, a pressuresensor 7056 may be placed on the bladder 7028 to provide fit informationto the control unit 7052 through a sensor connector 7058. In thisembodiment, if a loose fit is detected by pressure sensor 7056, i.e. thesensed pressure is low, a signal is sent to the control unit 7052 toincrease the pressure in the corresponding bladder 7028 until a highpressure is sensed and therefore a stable condition is achieved. In thisembodiment, the active control system adjusts the pressure of eachactuator 7024 in response to the part of the morphing residuum incontact with that actuator. This embodiment does not necessarilymaintain a constant fluid pressure in each bladder 7028 nor does itnecessarily maintain a total constant contact pressure against theresiduum. In addition to pressure sensors for each actuator 24, shown inFIG. 3, or actuator channel, in some embodiments, the control unit 8052may also include one or more pressure sensors detecting pressure withinthe manifold 8044, shown in FIG. 19C, which advantageously allows thecontrol unit 8052 to check one pressure measurement against another, ifdesired. This manifold pressure sensor is also advantageous whenincreasing the pressure in a particular actuator 24, shown in FIG. 3, oractuator channel. For example, the manifold pressure sensor allows thecontrol unit 8052 to first activate the pump 8048, shown in FIG. 19B, tobring the pressure within the manifold 8044, shown in FIG. 19C, to thatwhich may be desired within the actuator 24, shown in FIG. 3. Once thedesired pressure is achieved, the control unit 8052 may then open thevalve 8043, shown in FIG. 19C, connected to the actuator 24, shown inFIG. 3, to increase the pressure within the actuator 24, shown in FIG.3, without causing a momentary drop in pressure when the valve 8043,shown in FIG. 19C, is opened to connect the actuator channel to themanifold 8044, shown in FIG. 19C.

An alternative embodiment includes an active control system with sensors7056 and feedback loops that maintain constant pressure in each actuator7024. For example, in an embodiment having bladders 7028, the sensors7056 and feedback loops may be placed on each bladder 7028 or on eachfluid path 7030 of each bladder 7028. The sensors 7056 may be programmedto take an initial pressure reading of a bladder 7028. The sensors 7056then may take continuous pressure readings of the bladder 7028,comparing these readings to the initial pressure. As the bladderpressure changes, the sensors 7056 and feedback loops may send signalsto the control unit 7052, which may adjust the pressure in the bladder7028 to maintain the initial bladder pressure. Maintaining a constantpressure in the bladders 7028 may correspond to maintaining a constantfit between the support apparatus and the residuum.

Referring to FIGS. 23 and 24, the active control system may also includeEMG electrodes 7060 for providing control input to the control unit7052. The EMG electrodes 7060 may be placed between the actuator(s) 7024and the skin of the residuum 7012, on a separate layer or on eachactuator 7024. The EMG electrodes 7060 sense voluntary underlying muscleactivity and may be used to control some function of the prosthesis. Ina support apparatus having bladders 7028, the bladders 7028 control thedownward pressure of the EMG electrodes 7060 on the skin of the residuum7012. This control of the downward force may eliminate unintentionalrelative movement of the EMG electrodes 7060, which generates anartifact signal, which may be present with EMG electrodes. As theresiduum 7012 morphs or the patient puts loads on the residuum 7012, thepressure applied to each bladder 7028 by the residuum 7012 may vary,which in turn may vary the EMG electrodes' contact with the skin of theresiduum 7012. The pressure sensors sense this pressure differential,and the control unit may adjust the pressure of the bladder(s) 7028 soas to put pressure back on the EMG electrodes 7060. This pressure on theEMG electrodes 7060 pushes the EMG electrodes 7060 against the skin ofthe residuum 7012, which may enhance the maintenance of constant contactand a secure fit between the residuum and the support apparatus.

The control unit may include a partially-automatic control system forthe actuator(s) 24 with preset actuator pressures. The user has acontrol unit 52 that may be programmed with preset numbers or modes thatcorrespond to preset actuator pressures. These presets may be programmedby the patient while using the support apparatus 10 or may bepre-programmed by a clinician. The preset pressures may be set toaccommodate support apparatus fits for a resting mode, a light loadmode, a high load mode, a massage mode, or other types of activity.Depending on the patient's activity, the patient may select a number ormode on the control unit 52, which may automatically adjust the fit andpressure of the actuator(s) 24 to whatever pressure(s) was programmed tothat number. The massage mode may be utilized to facilitate circulationin the residuum. For example, the controller may turn off one actuator24 at a time to allow blood flow into the region of the turned offactuator 24. By cycling through the actuators one at a time, blood flowin the residuum 12 is assisted, with minimal loss of stability of thedynamic support apparatus 10.

The temperature control mechanism 19 of the dynamic support apparatus 10may include the apertures 20 of the support apparatus 10 in FIG. 2. Theapertures 20 allow for cooling by passive ventilation, which reducesmoisture and heat between the support apparatus 10 and the residuum 12.Additionally, the temperature control mechanism 19 may include ductedair flow over the skin of the residuum 12, heat exchangers, personalcooling systems (such as those found in Sharper Image's “PersonalCooling System”), ducted fans, or integrating sports or outdoorrecreation clothing designed for heat/moisture management. Thetemperature control mechanism 19 may be placed in a separate layerbetween the dynamic interface 16 or top surface 22 and the residuum 12,integrated into the same layer as the dynamic interface 16, orintegrated into the top surface 22 of the frame 14. An active controlsystem, similar to the system already described, may also be used tocontrol the temperature control mechanism 19 so as to maintain aconstant temperature, through the use of temperature sensors, betweenthe residuum 12 and the support apparatus 10.

Referring to FIG. 25, the temperature control mechanism 19 may includeone or more duct(s) 64 connected to a plurality of orifices 66 andintegrated into the dynamic interface 16. In this embodiment,temperature control is accomplished by supplying air through the duct(s)64 and the plurality of orifices 66 to impinge on the skin of theresiduum.

While the exemplary embodiment described above relates to upper-limbprosthesis for TH amputees, the support apparatus can be used fortransradial (TR) amputees and for shoulder disarticulation (SD)amputees. Referring now to FIGS. 26-28, one embodiment of a dynamicsupport apparatus 8010 for SD amputees includes a frame 8014, havingactuators 8024 and connectors 8026, connected to one or more activestraps 8068, such as McKibben artificial muscles. The term dynamicstrap, as used herein is synonymous with the active strap 8068. Eachactive strap 8068 contains at least one actuator and at least one strapconnector 8070 for connecting the actuator to the control system.Similar to those embodiments already described, each active strap 8068may also contain sensors and feedback loops for providing fitinformation to the control system. The active straps are connected tothe control system and control unit. Thus, as pressure and tension onthe active strap(s) 8068 change due to load variations on the residuum8012, the sensors signal the control unit to adjust the pressure of thestrap(s)'s actuator(s), which in turn adjusts the tension and length ofthe strap. These adjustments ensure a secure fit against the user's bodyand ensure stability of the prosthesis. The active straps 8068 and strapconnectors 8070 may be integrated with the dynamic interface 8016, suchthat one control system controls both the dynamic interface 8016 and theactive straps 8068 simultaneously. As should be understood by thoseskilled in the art, the strap connectors 8070 may alternatively berouted to a separate control unit specifically for the active straps8068.

Referring to FIG. 28, in addition to controlling the tension and lengthof active straps 8068 by actuators, each active strap 8068 mayadditionally contain a length adjuster 8072, which may be used tomanually adjust the length and fit of each active strap 8068.

Referring to FIGS. 29 and 30, in the exemplary embodiment havingbladders 8028 for actuators 8024 and fluid path connectors 8030 forstrap connectors 8070, the bladder 8028 is encased in a deformable strapmaterial 8074, such as nylon webbing. The bladder 8028 is connected tothe control system by the fluid path connector 8030. The end of eachactive strap 8068 has an attachment mechanism 8076 for attaching theactive strap 8068 to the frame. The active strap 8068 is in a presetcondition in FIGS. 29 and 30, having a strap length 8078 and a presetbladder cross-section.

Referring to FIGS. 31 and 32, the active strap 8068 is in an actuatedcondition having an actuated bladder cross section greater than thatshown in FIG. 30 and an actuated strap length 8080 that is less than thepreset strap length shown in FIG. 29. Accordingly, when instability isdetected in the support apparatus, either by the control system or bythe user, pressure may be increased in the active strap 8068, causingthe bladder 8028 to expand radially from the preset condition of FIGS.29 and 30 to the actuated condition of FIGS. 31 and 32. As pressureincreases in the bladder 8028, the deformable strap material 8074deforms, decreasing the length of the active strap 8068 and increasingstability in the support apparatus.

Referring to FIG. 33, the control system 8018 of each active strap 8068may be an electric pump 8048, such that the pressure in each activestrap 8068 may be adjusted independent of the other active straps 8068and the dynamic interface. Referring to FIG. 34, the control system 8018of each active strap 8068 may alternatively be a pressure bulb 8042,such that the pressure in each active strap 8068 may be adjustedindependent of the other active straps 8068 and the dynamic interface.Although shown as separate units in FIGS. 33 and 34, the control system8018 may be integrated with the bladder 8028 similar to that shown inFIGS. 20 and 21.

Unlike typical McKibben artificial muscles, which are used inhigh-pressure applications, the active straps 8068 in the dynamicsupport apparatus 8010 are operated under low-pressure conditions.Accordingly, various configuration changes have been made to theinflation, arrangement and strap characteristics of the active straps8068 to increase performance and efficiency in low-pressure conditions.The actuator length to strap length for the active strap 8068 is abouttwo-thirds the length seen in the prior art. This increases actuationwith less pressure, and makes the active strap 8068 and the supportapparatus more responsive. Additionally, when the actuator in activestrap 8068 is a bladder 8028, it may be fabricated wider than the strapitself so that the bladder 8028 can be inflated, causing the strapdiameter to increase, without putting energy into stretching the bladder8028 itself. Bladders that are fabricated by laser welding, such as thebladder 28 shown in FIG. 15, also provide for improved performance inlow-pressure conditions because they can be constructed to deform theactive strap 8068 in specific shapes and locations, rather than onlycircular deformation.

Referring to FIG. 50, an additional embodiment of a active strap 13068is shown. The active strap 13068 may include a flexible strap portion13081 having a bladder 13028 attached thereto. The active strap 13068 isconnected to the frame 13014 to secure the frame to the user's residuum13012. For example, the active strap 13068 may secure a trans-radialprosthetic support to the user's elbow. The bladder 13028 is operativelyconnected to the control system 18, shown in FIG. 1, through a fluidpath connector 13030. In operation, the active strap 13068 secures theframe 13014 to the residuum 13012, with the flexible strap portion 13081providing the active strap 13068 with strong tensile preload. Thebladder 13028 of the active strap 13068 may then be actuated while theframe is secured to the residuum 13012 to generate a normal force on theresiduum 13012 to alter the securing properties of the active strap13068. Thus, the bladder 13028 allows for remote adjustment of the fitof the support apparatus 10, shown in FIG. 1. The bladder 13028 alsoprovides the active strap 13068 with a measure of compliance and may aidin anchoring the frame 13014 to the residuum, i.e., to prevent sliding.Although the bladder 13028 is shown in a particular embodiment forexemplary purposes, it should be understood that the bladder 13028 maybe in the form of any of the various embodiments described herein. Forexample, as seen in FIG. 51, the bladder 14028 may include an accordionsidewall 14116 to allow for increased actuation.

Referring to the embodiment shown in FIGS. 35 and 36, attached to thesupport apparatus 8010 is a prosthetic interface 8082 for attaching aprosthesis (not shown) to the support apparatus 8010. The prostheticinterface 8082 is fixedly attached to the support apparatus 8010 byattachment means 8084, which may be rivets, bolts or any similar meansof attachment. The prosthetic interface 8082 has a prosthetic mount 8086for to which the prosthesis may be attached. The prosthetic mount 8086preferably includes a standard coupling configuration to facilitateattachment of the prosthesis. Although shown as holes 8088, it should beunderstood that the standard coupling configuration could also be a boltconfiguration that interfaces with corresponding holes on theprosthesis. The prosthetic interface 8082 should be rigid inconstruction, such that it does not bend or flex when the attachedprosthesis is used to lift a heavy object.

Referring to FIGS. 37-41, a method of fabricating the dynamic interfaceof the dynamic support apparatus may be a layer molding technique. Forexample, for the SD prosthesis support apparatus 8010, such method mayinvolve the steps of scanning the contour of a patient's residuum 8012in an outline 8090 where the frame will sit on the residuum 8012;flattening the scanned contour so that it can be made into a templatefor a mold 8092; machining the “flattened” template into the mold 8092;pouring silicone or similar material in the mold 8092 to half the finalthickness of the dynamic interface 8016 to create a first interfacelayer 8093; laying the actuator(s) 8024 and connector(s) 8026 on top ofthe first interface layer 8093; pouring silicone or similar material ontop of the actuator(s) 8024 and connector(s) 8026 to a desired thicknessof the dynamic interface 8016 to create a second interface layer 8094;removing the resulting dynamic interface 8016 from the mold 8092; andconnecting the resulting dynamic interface 8016 to a control system (notshown) and a frame 8014.

Although described with regard to the SD prosthesis support 8010, asseen in FIGS. 42-45, the dynamic interface 16 fabricated by the layermolding technique described above can also be applied to other types ofprosthesis support apparatuses by scanning the appropriate part of theresiduum 12 and attaching the resulting dynamic interface 16 to theframe 14 and control system.

An alternative method of fabricating a dynamic interface, for examplefor a TH prosthesis support apparatus, may involve the steps of scanningthe contour of a patient's residuum to form an inner mold of the THresiduum; forming the inner mold of the TH residuum; coating the innermold with an inner layer of liner made of material such as silicone orsimilar material; scanning the inner mold to generate an outer mold;forming an outer mold; laying the actuator(s) 24 and connector(s) 26 ontop of the inner layer of liner; pouring an outer layer of silicone orsimilar material on top of the inner layer, the actuator(s) 24, and theconnector(s) 26; using the outer mold to form the outer layer of thedynamic interface 16; and connecting the resulting dynamic interface 16to a control system 18 and a frame 14.

Referring back to FIG. 22, the frame 7014 may be capable of expanding oropening to facilitate donning and doffing the support apparatus. One ormore securing mechanisms 7096, such as snaps or latches, may be used toprevent expansion or opening of the frame 7014 while the supportapparatus 7010 is being worn by the user.

Referring to FIGS. 46-49, in an alternative embodiment, the supportapparatus 9010 may be capable of expanding or opening parallel to itslongitudinal axis to facilitate donning and doffing. An opening 9098 ofthe frame 9014 may run along only a portion of the length of the supportapparatus 9010 or may run along the entire length of the supportapparatus 9010 from the proximal to the distal end of the apparatus. Thesecuring mechanism 9096 may be flexible, such as a circumferentialstraps, or more rigidly articulated with mechanical mechanisms toprevent expansion or opening of the frame while the support apparatus isbeing worn by the user. In this embodiment, the dynamic interface 9016may be composed of multiple portions, each being attached to a part ofthe frame 9014.

Some embodiments may also include an exhaust system that is incorporatedinto the control system. The exhaust system may channel excess gasresulting from the release of pressure in the actuators to one or moreexhaust outlets. In the exemplary embodiment, with air as the fluid, theexhaust outlets may vent the air into the atmosphere. In otherembodiments, the exhaust outlets may channel the air into a reservoir,from which the air can be drawn back into the system to increasepressure. These exhaust outlets may also be strategically positioned orducted along the frame to channel flow over the surface of the residuum.This flow could aid convective cooling of the residuum.

The dynamic interface is able to change geometry to provide a fit withthe residuum 12. The user may manually actuate the dynamic interface toincrease stability as needed. The dynamic support apparatus 10 mayinclude a temperature control system to increase the comfort of thedynamic support apparatus. The frame may be capable of opening to assistthe user in donning and doffing the dynamic support apparatus.

The control system may actively actuate the dynamic interface based onfit information provided by sensors. The control system may includepreset modes such that the fit may be changed for each mode. The controlsystem may include a massage mode for increasing blood circulation inthe residuum.

Referring to FIG. 52, in some embodiments, the prosthesis (not shown)itself may send signals to the control unit 10052 of the active controlsystem 10018 so that the control unit 10052 may adjust the dynamicinterface 10016 of the support apparatus 10010 based on the currentusage of the prosthesis (not shown). For instance, the prosthesis (notshown) may send load signals 10100 indicative of the loading of theprosthesis (not shown). The load signals 10100 may be provided to thecontrol unit 10052 by force sensors, compliance sensors and/or motorswithin the prosthesis (not shown). The prosthesis (not shown) may alsosend function signals 10102 to the control unit 10052 indicative of amode of operation of the prosthesis (not shown) and/or of a currentpositioning of the prosthesis (not shown). The load signals 10100 andthe function signals 10102 may be transmitted to the control unit 10052through a wired connection or wirelessly, for example, throughBluetooth, radio or the like.

The load signals 10100 and the function signals 10102 allow the controlsystem 10018 to actively alter the type and level of support provided tothe prosthesis (not shown) by the support apparatus 10010. For example,the control unit 10052 may compensate for load signals 10100 indicatinghigh loading of the prosthesis (not shown) by increasing the actuationof the actuators 10024 of the support apparatus 10010 to better securethe support apparatus 10010 to the residuum 12, shown in FIG. 1.Similarly, the control unit 10052 may compensate for load signals 10100indicating low loading of the prosthesis (not shown) by decreasing theactuation of the actuators 10024 to loosen the interface between thesupport apparatus 10010 and the residuum 12, shown in FIG. 1. Thus, thecontrol unit 10052 is able to provide increased support to theprosthesis (not shown) when necessary and to loosen the support to allowfor improved blood circulation in the residuum, shown in FIG. 1, duringlower loading conditions. The function signals 10102 may also provideimproved control to the prosthetic support apparatus 10010. Forinstance, the function signals 10102 may indicate a current mode ofoperation of the prosthesis (not shown), which may allow the controlunit 10052 to alter the support provided by the support apparatus 10010to suit the operating mode. For example, if the function signal 10102indicates that the prosthesis (not shown) has entered a standby mode,the control unit 10052 may decrease actuation of the actuators 10024 orenter a massage mode to increase blood circulation in the residuum 12,shown in FIG. 1. Additionally, the function signals 10102 may provideinformation to the control unit 10052 indicating a current position ofthe prosthesis (not shown), for example, through position sensors suchas potentiometers, magnetic sensors, Hall effect sensors and the like.Using these function signals 10102, the control unit 10052 may actuatespecific actuators 10024 more than others to provide greater support incertain areas of the support apparatus 10010 based on the position ofthe prosthesis (not shown). Thus, the load signals 10100 and thefunction signals 10102 may provide for improved active control of theprosthetic support apparatus 10010 based on detected function or loadsthat the prosthesis (not shown) is imparting on the support apparatus10010 so that the support apparatus 10010 may adjust appropriately.

In various embodiments, the support apparatus 10010 may additionallyinclude perfusion sensors 10104, in communication with the control unit10052, to determine the amount of blood flowing in tissue of theresiduum 12, shown in FIG. 1, underneath the areas of contact with theactuators 10024. For example, referring to FIG. 53, in some embodiments,the perfusion sensor 10104 may be a pulse oximeter 10106 for detectingwhether or not the skin is adequately perfused. In other embodiments,the perfusion sensor 10104 may be a blood volume pulse sensor fordetecting blood flow within the residuum 12, shown in FIG. 1. If theskin is not, the control unit 10052 may decrease actuation of one ormore of the actuators 10024 and/or enter a massage mode to increaseblood circulation in the residuum 12, shown in FIG. 1.

Referring to FIGS. 54-56, in some embodiments, the support apparatus 10,shown in FIG. 1, may include bladders 11028 having a lateralstabilization system 11108. The lateral stabilization system 11108includes a base plate 11110 and a cover plate 11112 having the bladder11028 disposed therebetween. The base plate 11110 may be fixedly securedto the frame 11014 of the support apparatus 10, shown in FIG. 1. Thebase plate 11110 and the cover plate 11112 are pivotally connected toeach other by a linkage 11114, which is preferably a four bar linkage.The linkage 11114 substantially prevents the cover plate 11112 frommoving in the lateral direction L relative to the base plate 11110,while allowing the cover plate 11112 to pivot in the transversedirection T away from and back toward the base plate 11110, as seen inFIG. 56. The bladder 11028 may include an accordion sidewall 11116 toprovide an increased actuation distance D that the cover plate 11112 maybe actuated away from the base plate 11110, and the lateralstabilization system 11108 ensures that lateral stability is not lost asthe bladder 11028 actuates to the increased actuation distance D.

The cover plate 11112 preferably includes a residuum contact surface11118 that is contoured to improve user comfort, for example, byproviding rounded corners 11120 that will not dig into the residuum 12,shown in FIG. 1. In other embodiments, the contact surface 11118 may becontoured to the shape of the user's residuum to increase comfort.Referring to FIG. 54, the cover plate may also include one or moresensor cavities 11122 for accommodating one or more sensors 11056 formonitoring the fit of the support apparatus 11010 and the condition ofthe residuum 12, shown in FIG. 1. The sensors 11056 may be, for example,force sensors, pressure sensors, temperature sensors, perfusion sensorsor the like. Preferably, the base plate 11110 and the cover plate 11112are also formed to improve user comfort, for example by being formedfrom a lightweight material such as an open-cell foam.

Referring to FIG. 57, the bladders 11028 having the lateralstabilization systems 11108 may be arranged around the support apparatus11010 in a manner similar to those discussed above.

Referring to FIG. 58, in operation, the user may insert their residuum11012 into the support apparatus 11010 in the transverse direction T,while the bladders 11028, shown in FIG. 55, having the lateralstabilization systems 11108 are in an inactuated state. Since thelateral stabilization system 11108 provides for the increased actuationdistance D, shown in FIG. 55, when inactuated, the cover plate 11112 maybe completely out of contact with the residuum 11012. Thus, the user mayinsert their residuum 11012 easily, without a mushrooming of the softresiduum tissue that may be caused by contact with the support apparatus11010. Then, referring to FIG. 59, the bladders 11028 may be actuated,causing them to expand. As the bladders 11028 expand, they push thecover plates 11112 away from the base plates 11110. The linkage 11114connecting each cover plate 11112 to each base plate 11110 pivots toallow the cover plate 11112 to move away from the base plate 11110,while maintaining lateral stability. The cover plates 11112 are actuatedinto contact with the residuum 11012 to secure the support apparatus11010 to the residuum 11012. To remove the support apparatus 11010, thebladders 11028 may simply be returned to their inactuated states, asseen in FIG. 58, and the residuum 11012 may be withdrawn from thesupport apparatus 11010.

The lateral stabilization system 11108 is advantageous because inprevents unintentional removal of the residuum 11012 from the supportapparatus 11010, for example, due to slippage or the like. Specifically,if the residuum 11012 begins to move in the transverse direction T whilethe bladders 11028 are actuated and in contact with the residuum 11012,the movement will create a camming effect, pulling on the cover plate11112 and causing the cover plate 11112 to pivot further away from thebase plate 11110. As the cover plate 11112 moves further from the baseplate 11110, the contact force against the residuum 11012 is increased,securing the support apparatus 11010 more tightly thereto. Thus, thelaterally stabilized bladders 11028 provide an improved securinginterface when actuated, yet also allow for ease of donning and doffingwhen inactuated, as discussed above.

Referring to FIG. 60, in some embodiments, the lateral stabilizationsystem 11108 may be provided with one or more resilient members 11124connecting the cover plate 11112 to the base plate 11110 and applying acompressive force therebetween. For example, the one or more resilientmembers 11124 may be elastic members, spring members or the like. Theone or more resilient members 11124 ensure that the cover plate 11112pivots back into contact with the base plate 11110 when in an inactuatedstate.

Although described in connection with the exemplary embodiment, itshould be understood that various changes to the bladders 11028 andlateral stabilization system 11108 may be made. For example, in someembodiments, the bladder 11028 may be anchored directly to the supportapparatus 11010, eliminating the need for the base plate 11110. In thisembodiment, the linkage 11114 may be pivotally connected directly to thesupport apparatus 11010. In some embodiments, rather than the bladder11028 with accordion sidewall 11116, two or more bladders withoutaccordion sidewalls may be arranged between the cover plate 11112 andthe base plate 11110 to provide the increased actuation distance D. Inother embodiments, the linkage 11114 may be telescopic, rather thanpivotal, thereby providing stability in both the lateral and transversedirections. Additionally, although each bar of the linkage 11114 isshown as being substantially the same length, the lengths may be variedto alter the configuration of the cover plate 11112 relative to the baseplate 11110. For example, rather than being parallel to the base plate11110, the cover plate 11112 may instead be angled to one side in thelateral direction L or angled to the front or back in the transversedirection T.

Although the lateral stabilization system 11108 has been described assurround the bladder 11028, in other embodiments, the bladder 11028 mayinclude an open cell foam structure disposed inside the bladder 11028 tocreate internal struts and connectors, which are flat when the bladder11028 is deflated. In operation, the bladder 11028 is anchored to thebase plate 11110 or frame 11014. As the bladder 11028 inflates, thebladder 11028 the structure of the foam or material inside the bladder11028 provides the bladder 11028 with lateral stability. In someembodiments, the open cell foam structure may be toroidal. In variousother embodiments, a honeycomb or multi-tube structure may be introducedto provide greater lateral stability when the bladder 11028 is inflated.

In various embodiments, bladder inflation may be accomplished by usingcompressed gas from a tank, such as carbon dioxide (CO₂), rather thanair supplied by a pump. For example, referring to FIG. 61, the controlsystem 12018 may include one or more CO₂ cartridges 12126. The CO₂cartridges are advantageous because they may quickly fill the bladders28, shown in FIG. 3. Additionally, the CO₂ cartridges are themselvesrefillable, so they may simply be removed from the control system 12018to be refilled or replaced. Inflation using the one or more CO₂cartridges 12126 may also improve the temperature control mechanism 19,shown in FIG. 1, because the CO₂ may decrease in temperature as itexpands to fill the bladders 28, shown in FIG. 3, thereby cooling theuser where the user is in contact with the bladders 28.

Depending upon the degree of amputation of the user of the prostheticarm, in some embodiments, it may be desirable to couple some degree ofmovement of the user's arm with a shortened prosthetic arm, for example,a prosthetic arm that provides only wrist flexion and hand movementcapabilities. Thus, referring to FIG. 62, a trans-radial socket 13128may be provided for trans-radial amputees that are still able to pronateand supinate their residuum (not shown). The trans-radial socket 13128includes a bracket body 13130 connected to a cup brace 13132 by twohinged brackets 13134. The bracket body includes an outer cylinderportion 13136 attached to the hinged brackets 13134 and an inner tubularportion 13138 partially rotatably fixed within the outer cylinderportion 13136 and extending axially outward therefrom to a distal end13140. In operation, the prosthetic arm (not shown) is mounted to thetrans-radial socket 13128 at the distal end 13140 of the inner tubularportion 13138. The user may then insert their residuum into the innertubular portion 13138. The cup brace 13132 may then be slid along theirupper arm behind the user's elbow. The hinged brackets allow the user tobend their elbow to move the bracket body 13130. Additionally, the usermay pronate and supinate their residuum, to rotate the inner tubularportion 13138 relative to the outer cylinder portion 13136, which inturn causes the prosthetic arm mounted to the inner tubular portion13138 to rotate. Thus, the trans-radial socket 13128 provides for areduction in the size of the prosthetic arm by eliminating the need fora wrist rotator for users having natural rotation capability in theirresiduum. This reduction in the size of the prosthetic arm results in acorresponding reduction in weight of the prosthetic arm, therebyimproving user comfort. Additionally, the trans-radial socket 13128eliminates the need for the prosthetic arm to provide wrist rotation,thereby making the prosthetic arm easier for the user to control byreducing the number of joint movements for which the user must learn newcontrol inputs. Additionally, reducing the number of joint movementsprovided by the prosthetic device may also improve battery power usageand lead to extended battery life.

Referring to FIG. 63, an embodiment of a dynamic support system 142 isshown. In some embodiments, the dynamic support system 142 includes bothhardware and control components for controlling the hardware. In someembodiments, the hardware may be the dynamic support apparatus 10, whichmay include, but is not limited to, one or more of the following: atleast one dynamic interface 16, which may include, but is not limitedto, bladder actuators 28, shown in FIG. 3, and or strap actuators 8068,shown in FIG. 28, connectors 8026, shown in FIG. 28, such as tubingand/or other elements to support integration of the dynamic supportapparatus 10. The dynamic support system 142 therefore may include thecontrol systems 18 for executing control logic and/or one or moremethods for controlling the one or more dynamic interfaces 16 using, forexample, connectors 8026, shown in FIG. 28, such as tubing, and in someembodiments, other hardware elements. In some embodiments, the dynamicsupport apparatus 10 and the control system 18 for the dynamic supportapparatus 10 may be used with a prosthesis 11 similar to one or moreembodiments described in U.S. patent application Ser. No. 12/706,609,filed Feb. 16, 2010, which is hereby incorporated by reference in itsentirety. Additionally, the dynamic support apparatus 10 may be usedtogether with control systems, such as arm controller 143 for theprosthesis 11, which may be similar to one or more embodiments describedin U.S. patent application Ser. No. 12/706,575, U.S. patent applicationSer. No. 12/706,471, U.S. patent application Ser. No. 12/027,116, andU.S. patent application Ser. No. 13/088,085, filed Apr. 15, 2011, eachof which is hereby incorporated by reference in its entirety. In someembodiments of the dynamic support system 142, the dynamic supportapparatus 10 is in communication with both the user's residuum 12 andthe prosthesis 11 and is, therefore, able to vary its configuration asthe state of the residuum 12 and/or the prosthesis 11 changes. Forinstance, as discussed above, the dynamic support apparatus 10 includesa variety of sensors for detecting the condition of the residuum, suchas temperature sensors and perfusion sensors 10104, shown in FIG. 52.Additionally, as discussed above, the dynamic support apparatus may alsoreceive prosthesis load information 10100 and prosthesis functioninformation 10102, shown in FIG. 52, from the prosthesis 11. The dynamicsupport system 142 also includes a variety of interface sensors, such aspressure sensors 7056, shown in FIG. 22, detecting the condition of theinterface between the residuum 12 and the dynamic support apparatus 10.Information from all of these various sensors and sources are used inthe dynamic support system 142 to alter the state of the dynamicinterface 16, thereby changing the fit of the dynamic support apparatus10. The dynamic support system 142 may also include interfacestimulators 144 to provide feedback to the user regarding the state ofthe dynamic interface 10. For instance, the dynamic support system 142may use tactors 146 to provide vibration or other tactile feedback tothe user. Additionally, the dynamic support system 142 may also includea variety of passive elements for improving comfort and/or fit of thedynamic support apparatus 10 and/or for communicating information to theuser. For instance, the apertures 20 provide passive temperature controland the contact between the dynamic support apparatus 10 and theresiduum 12 acts as a passive loading interface stimulator. Thus, thedynamic support system 142 provides beneficial integration between thedynamic support apparatus 10, the prosthesis 11 supported by the dynamicsupport apparatus 10 and the user.

Referring now to FIGS. 64A and 64B, in some embodiments, the controlsystem 18, shown in FIG. 63, includes control unit 8052 (or dynamiccontroller apparatus). The control unit 8052 may be a portableelectronic device that may be worn on the dynamic support apparatus 8010and/or on a belt or other part of a user's clothing. As shown in FIG.64A, the user is wearing the control unit 8052 on a belt. The controlunit 8052 is an interface between the dynamic support system 8142 andthe user. The control unit 8052 allows the user to control the mode andinflation state of the dynamic support apparatus 8010, and in someembodiments, may indicate the state and or mode of the dynamic supportapparatus visually and/or using audio. In some embodiments, the controlunit 8052 includes a user interface (not shown) which may include, butis not limited to, one or more of the following: one or more buttons,one or more capacitive switches, one or more jog wheels, one or moremonitors, one or more LEDs or other lights, and/or one or more speakers.The control unit 8052 may be in communication with a prosthetic devicecontroller, such as arm controller 143 for the prosthesis 11, both shownin FIG. 63, and/or may be integrated with the prosthetic devicecontroller and may provide advanced information related to functionalactivity of the prosthesis 11, shown in FIG. 63. As discussed above, anexample of a prosthetic device controller is described in U.S. patentapplication Ser. No. 12/706,609 and an example of various controlmethods and systems for a prosthetic device may be found in U.S. patentapplication Ser. No. 12/706,575 and U.S. patent application Ser. No.12/706,471. The control unit 8052, in various embodiments, is attachedto the dynamic interfaces 8016 of the dynamic support system 8142, e.g.,actuators 8024 such as bladders 8028 and/or straps 8068, by way ofconnectors 8026, e.g. flexible tubing; for example, clear flexibletubing in a flat ribbon configuration as seen in FIG. 64B.

In some embodiments, the control unit 8052 may include multiple userinputs 8055, shown in FIG. 19A, for example, buttons, each to activate aparticular/specific support apparatus control mode. For example, in someembodiments, one or more buttons may be used to function as describedbelow, however, other embodiments may include additional functionalityand still other embodiments may include a “function” or “toggle” switchso as to use the same button or user input 8055, shown in FIG. 19A, formultiple functionalities.

In some embodiments, the control unit 8052 may include a VENT button(not shown) that, when pressed, may signal the control system 18, shownin FIG. 63, to control all actuators 8024, such as bladders 8028 to ventand deflate, thereby allowing easy donning and doffing of the dynamicsupport apparatus 8010. In some embodiments, where air is used toinflate and deflate actuators 8024, the vented air may be routed backinto the dynamic support apparatus 8010 and across the user's skin toprovide a moderate cooling effect, for example as discussed inconnection with ducts 64 and orifices 66, shown in FIG. 25.

In some embodiments, the control unit 8052 may include a pressure UPbutton (not shown) that, when pressed from the vented (evacuated) ornon-actuated state, may signal the control system 18, shown in FIG. 63,to actuate or inflate all the actuators 8024, such as bladders 8028, ina preprogrammed sequence up to a Baseline inflation pressure. Thispressure UP button (not shown) may advantageously be used in someembodiments of a donning process. The Baseline pressure, in someembodiments, may be a pressure that permits the dynamic supportapparatus 8010 to be worn for long periods of time while providingenough stability for moderate activity with the prosthesis 11, shown inFIG. 63. The relationship between the inflation pressure and the contactpressure on the user's tissue is dependent upon a variety of factorsincluding characteristics of the actuators 8024, any tissue preload, thecompliance of the soft tissue and the like.

In some embodiments, when the actuators 8024 of the dynamic supportsystem 142, shown in FIG. 63, are already actuated or inflated, thepressure UP button (not shown) may be used to increase a currentpressure setpoint in discrete steps up to a programmed High pressuresetting. For example, in some embodiments, the user may press thepressure UP button (not shown) before or during heavier or high-loadactivity with the prosthesis 11, shown in FIG. 63. The High pressuresetting, in some embodiments, may be used to provide maximum grip andstability of the dynamic support apparatus 8010 with the user within thelimits of the dynamic support system 142, shown in FIG. 63. In someembodiments, the High pressure setting is not be intended for all-dayuse, i.e., the control system 18, shown in FIG. 63, may be preprogrammedto limit to amount of time in the High pressure setting to avoidnegative effects to the tissue of the user. In some embodiments, thecontrol system 18, shown in FIG. 63, may be pre-programmed such thatafter meeting a threshold of time in the High pressure setting,additional pushes of the pressure UP button (not shown) may be ignored.

In some embodiments, the control unit 8052 may include a pressure DOWNbutton (not shown) that, when pressed, decreases the current pressuresetpoints for all channels, in a stepwise down fashion, until apre-programmed Low pressure setting is reached. The Low pressure settingmay be the minimum inflation that permits the support to remain stableon the user with the weight of the prosthesis 11, shown in FIG. 63, andpermit very minimal activity, e.g., but not limited to, sitting in achair. In some embodiments, once the Low pressure setting is reached,additional pushes of the DOWN button (not shown) may be pre-programmedto be ignored by the control unit 8052.

In some embodiments, the control unit 8052 may include a MASSAGE button(not shown) for controlling the dynamic support system 142, shown inFIG. 63, to enter massage mode. Depression of the MASSAGE button maycause a subset of the bladders 8028 to, one at a time, decrease pressurefrom the current pressure setpoint to provide relief to the tissueunderneath the bladder 8028. For example, when the bladders 8028 aremostly or heavily inflated, one bladder 8028 at a time will deflate tothe Low pressure setting, remain there for several seconds, and thenre-inflate to the current pressure setpoint. The next bladder 8028 thendeflates, etc. In some embodiments, where the current pressure setpointis already near the Low pressure setting, the selected bladder 8028 mayinflate up to the Baseline pressure setting or higher before returningto the Low pressure setting. The massage mode may cycle once or manytimes, depending on user preference, and, in some embodiments, may beexited at any time by pressing any of the other buttons of the controlunit 8052.

In some embodiments, in addition to the various buttons discussed above,and additional buttons which may be used on the dynamic control unit8052, the dynamic support system 142, shown in FIG. 63, may include oneor more remote user inputs and/or buttons which may be positionedelsewhere on the user's body, on the dynamic support apparatus 8010and/or on the prosthesis 11, shown in FIG. 63. Depending on the type ofuser inputs and where they are mounted, a software application mayconfigure the inputs and the resulting functionality to accommodate userneeds and/or preferences. In some embodiments, a single input may bedesired and may replicate the functionality of multiple buttons.However, in various other embodiments, one or more buttons and/or userinputs may be positioned remotely from the control unit 8052.

In some embodiments of the dynamic support system 142, shown in FIG. 63,the dynamic actuators 8024 may include settings, for example, but notlimited to, the low, baseline, and high pressure modes discussed above.These settings may, in some embodiments, be unique to the user andtherefore may be preprogrammed and/or re-programmed depending on theuser's needs.

As one mere example for illustrative purposes, the following exemplarydescription of possible configurations of user customization based onuser needs is provided. This exemplary description is provided only forillustrative purposes and is in no way limiting, as should be understoodby the very customizable characteristics of the settings of the dynamicsupport system 142, shown in FIG. 63. With respect to the variousembodiments of the actuators 8024 (which, may include bladders 8028and/or straps 8068 with inflatable elements), in some illustrativeembodiments, the actuator settings may be typically inflated topressures of ˜4 psi (200 mmHg) for a nominal fit of the dynamic supportapparatus 8010, and ˜7 psi (350 mmHg) where enhanced fixation is needed.In some exemplary embodiments, approximately 70% of the inflationpressure plus a constant related to static preload may be required toexpand the bladder membrane to the volume typically used in the system.Thus, in some embodiments, actual tissue contact pressures may thereforebe approximately 30% of the inflation pressures plus the constantrelated to static preload. Similarly, in some exemplary embodiments, theretaining straps 8068 may be pressurized to 2 psi-4 psi (100 mmHg-200mmHg) for a nominal fit, and pressures of 6 psi-10 psi (300 mmHg-500mmHg) for a more secure fit. In some embodiments, the forces generatedby the load straps 8068 may be of a similar magnitude as may begenerated with manual VELCRO and other strapping systems. Operatingpressures may exist on a continuum and may be customized to the user forbest fit. The typical pressures discussed herein are for staticconditions; during activity these pressures may be higher or lowerdepending on the loads being transferred through the dynamic supportapparatus 8010. In some embodiments, these “typical” pressures may bereferred to as the “Baseline” pressures discussed above, which arepressures from which a deflation or inflation may be desired and/ornecessary depending on one or more factors, including, but not limitedto, user activity.

Referring back to FIG. 63, various embodiments of the dynamic supportsystem 142 may provide benefits to the user which may include, but arenot limited to, one or more of the following: increased prosthesisstability through improved engagement with the muscle-skeletal system ofthe user's residuum 12; increased ease of user adjustment of actuatorforce based on user activity; and/or reduced don/doff effort. Thevarious embodiments of the control system 18 for the dynamic supportapparatus 10 may more readily meet the immediate needs of the user andthus provide a varying degree of support to the user in accordance withthe activity being performed by the user. In this way, the dynamicsupport apparatus 10 is dynamic and, thus, the pressure of one or moreactuators 8024, shown in FIG. 64A, may vary with activity levels andneeds of the user.

Referring now to FIG. 65, an embodiment of a method for donning thedynamic support system 142, shown in FIG. 63, is shown. In someembodiments, the user first locates the dynamic support apparatus 10,shown in FIG. 63, onto their body at 158. Then, at 160, the useractivates the control system 18, shown in FIG. 63, indicating that thedynamic support apparatus 10, shown in FIG. 63, has been donned. At 162,the control system 18, shown in FIG. 63, in some embodiments, mayinflate the one or more bladders 8028, shown in FIG. 64A, and/or strapactuators 8068, shown in FIG. 64A to the baseline pressure. Thisbaseline pressure may be as discussed above and/or may be anypre-determined pressure from which deflation or inflation may be desiredand/or necessary depending on one or more factors, including, but notlimited to, user activity. It is the baseline pressure that serves as a“zero” or neutral pressure and from which inflation and deflation ismeasured.

Referring now to FIG. 66, once the pressure setpoint has been reached at162, in some embodiments, the control system 18, shown in FIG. 63, mayshut-down/close the various valves and pumps at 163. Once the valves andpumps are closed/shutdown, the dynamic interface 16, shown in FIG. 63,becomes a closed system at 164 since, aside from leakage, no air entersor exits the bladders 8028, shown in FIG. 64A, and straps 8068, shown inFIG. 64A. The control system 18, shown in FIG. 63, may then begin a leakcompensation mode at 165 for detecting leaks from the closed systemmaintaining the baseline pressure or the current pressure setpoint inthe actuators 8024, e.g. bladders 8028 and straps 8068, shown in FIG.64A.

In various embodiments, the leak compensation mode may includemonitoring the pressure of each actuator 8024, shown in FIG. 64A, overtime at 165. For example, in some embodiments the control system 18,shown in FIG. 63, may read the pressure of each bladder 8028, shown inFIG. 64A, at pre-determined intervals, e.g., every 0.1 seconds. At 166,the control system 18, shown in FIG. 63, determines whether there hasbeen a change in the pressure of one or more actuators 8024, shown inFIG. 64A. For example, in some embodiments, the control system 18, shownin FIG. 63, may compare the instantaneous pressure of each actuator8024, shown in FIG. 64A, to the desired setpoint pressure for thatactuator 8024, shown in FIG. 64A, at pre-determined intervals (e.g. inone mere exemplary embodiment, every 60 seconds). Where the sampledinstantaneous pressure is lower than the desired setpoint pressure, at167, the control system 18, shown in FIG. 63, may command the pump 8048,shown in FIG. 19B, to add air to that channel in order to increase thepressure in the actuator 8024, shown in FIG. 64A, to the desiredsetpoint pressure. Conversely, where the sampled instantaneous pressureis greater than the desired setpoint pressure, at 167, the controlsystem 18, shown in FIG. 63, may open the valve 8043, shown in FIG. 19C,associated with the actuator 8024, shown in FIG. 64A, to vent air fromthe channel in order to decrease the pressure in the actuator 8024,shown in FIG. 64A, to the desired setpoint pressure. In someembodiments, a hysteresis or deadband may be added about the pressuresetpoint to provide a range of acceptable pressures about the pressuresetpoint where no pumping or venting action is required. This hysteresisor deadband advantageously reduces the amount of work required by thecontrol system 18, shown in FIG. 63, without greatly sacrificing thestability of the prosthesis 11, shown in FIG. 63.

While determining actuator pressures changes by comparing theinstantaneous pressure to the desired pressure setpoint may beadvantageous in some situations for detecting pressure changes at 166,such as during low activity, in other situations, this control mayresult in unnecessary air pumping and/or venting. For instance, when theprosthesis 11, shown in FIG. 63, is raised up or carrying a load, themechanical forces transmitted by the prosthesis 11, shown in FIG. 63,through the dynamic support apparatus 10, shown in FIG. 63, to theuser's residual anatomy 12, shown in FIG. 63, will cause the pressure ineach channel and actuator 8024, shown in FIG. 64A, to fluctuate withrespect to the setpoint pressure. For example, some actuators 8024,shown in FIG. 64A, will undergo compression and have elevated pressureswhile other actuators will have lower pressures. Thus, if the controlsystem 18, shown in FIG. 63, controls pumping and/or venting based onthe instantaneous pressure in these actuators 8024, shown in FIG. 64A,the control system 18, shown in FIG. 63, is likely to add and/or removeair from the actuators 8024, shown in FIG. 64A, unnecessarily.

Therefore, in some embodiments, the control system 18, shown in FIG. 63,may maintain a constant amount (i.e. mass or mols) of air in eachactuator channel, thereby rarely venting and essentially only pumping tomake up air lost due to leaking. For example, the control system 18,shown in FIG. 63, may use the monitored pressure over time in eachactuator 8024, shown in FIG. 64A, or actuator channel as a proxymeasurement to estimate the amount of air in each actuator channel. Inusing the monitored pressure to estimate the amount of air in eachactuator channel, the assumption is made that, on average, the loadingon the actuators is constant, which turns out to typically be true, asthe user tends to keep the prosthesis 11, shown in FIG. 63, in aneutral, unloaded position near the body and any external loading istransient. Therefore, to estimate the amount of air in each actuatorchannel, the control system 18, shown in FIG. 63, passes the monitoredpressure signal through a low-pass filter 168 (FIG. 67) having abandwidth sufficiently low to remove most of the pressure transientsfrom the signal. For example, in some exemplary embodiments, thelow-pass filter 168 (FIG. 67) may have a bandwidth of less than 0.1 Hz.In other exemplary embodiments, the low-pass filter 168 may have otherdesired bandwidths. With the pressure transients removed from thepressure signal any remaining variations in the filtered pressure signalshould be the result of air leakage from the actuator channel or gradualchanges in the shape of the residual anatomy 12, shown in FIG. 63, thatresult from the wearing of the dynamic support apparatus 10, shown inFIG. 63, changes in temperature and/or other physiological responses.Thus, the control system 18, shown in FIG. 63, may monitor the low-passfiltered pressure signal at 166 and, periodically, supply additional airto the actuators 8024, shown in FIG. 64A, at 172 to account for leaksand the like.

In some embodiments, the control system 18, shown in FIG. 63, may usepulse density modulation control to apply brief pulses of air to eachactuator channel to compensate for leakage. Each pulse of air isseparated by an idle time between pulses Δt in which air is not beingsupplied. As the leak rate from a particular actuator channel increases,the time between pulses Δt for that channel is decreased by the controlsystem 18, shown in FIG. 63. When the control system 18, shown in FIG.63, is in equilibrium, the averaged effect of the air pulses for aparticular actuator channel, in various embodiments, shouldsubstantially match the effect of air leakage from that actuatorchannel. The control system 18, shown in FIG. 63, includes control logicfor calculating the time between pulses Δt for each actuator channelbased on the low-pass filtered pressure measured in that channel. Insome embodiments, the control logic for determining the time betweenpulses Δt may be a function of an error parameter E, e.g. a measurementof how far from the desired pressure setpoint the actuator pressure is.In some embodiments, the function may be exponential and may take theform:Δt=f(E)=Δt _(max)·exp(−α·E)where

${\alpha = {\frac{1}{E_{\max}}{\ln\left( \frac{\Delta\; t_{\max}}{\Delta\; t_{\min}} \right)}}};$

-   -   ΔL_(max) is a preset maximum allowable time between pulses;    -   ΔL_(min) is a preset minimum allowable time between pulses; and    -   E_(max) is a preset maximum allowable error.

In this embodiment, when the error parameter E becomes smaller (i.e.approaching zero), the time between pulses Δt should grow towards themaximum time ΔL_(max). Conversely, when the error parameter E becomeslarger (i.e. approaching the maximum allowable error E_(max)) the timebetween pulses Δt should shrink towards the minimum time Δt_(min). Whena particular actuator channel is being supplied air pulses separated byminimum time ΔL_(min) the control effort is considered saturated.Although shown as a exponential function, it should be understood bythose skilled in the art that the relationship between the time betweenpulses Δt and the error parameter E could take many forms including alinear function, a quadratic function, a cubic function or any othersimilar polynomial function. For example, a linear relationship may berepresented by the equation:

${\Delta\; t} = {{f(E)} = {{\Delta\; t_{\max}} - {\frac{E}{E_{\max}} \cdot \left( {{\Delta\; t_{\max}} - {\Delta\; t_{\min}}} \right)}}}$Preferably, at the time that the control system 18, shown in FIG. 63,applies one pulse of air, the control system 18, shown in FIG. 63,calculates the time between pulses Δt to the next pulse and schedulesthe pulse to occur. In embodiments where each actuator channel operatesindependently, the calculation of Δt may also be performed independentlyfor each channel such that the resulting air pulses occurasynchronously.

The error parameter E may advantageously be determined in a variety ofdifferent ways. Referring to FIG. 67, an embodiment, for determining theerror parameter E for a particular channel i at time interval n isshown. In this embodiment, the error parameter E_(ni) equals anError_(ni) calculated from the difference between the pressure setpointP_(setpoint) _(ni) and the monitored pressure P_(ni) after passingthrough the low-pass filter 168. In this embodiment, when the monitoredpressure P_(ni) passed through the low-pass filter 168 is lower than thepressure setpoint P_(setpoint) _(ni) , e.g. due to air leakage from thechannel i, the error parameter E_(ni) is positive.

Referring to FIG. 68, in some embodiments, the error parameter E for aparticular channel i at a given time interval n may be determined by thecontrol system 18, shown in FIG. 63, using aproportional-integral-derivative (PID) controller 169 having aproportional portion 170, an integral portion 171 and a derivativeportion 172. In these embodiments, the control system 18, shown in FIG.63, first calculates Error_(ni) from the difference between the pressuresetpoint P_(setpoint) _(ni) and the monitored pressure P_(ni) afterpassing through the low-pass filter 168 in substantially the same manneras that discussed in connection with FIG. 67. The control system 18,shown in FIG. 63, then processes the signal Error_(ni) through the PIDcontroller 169 and takes a weighted sum of the output signals from theproportional portion 170, the integral portion 171 and the derivativeportion 172 to determine E_(ni). In the proportional portion 170,Error_(ni) is multiplied by a gain factor k₁, which, in someembodiments, may simply equal 1, to provide a weighted output signalrepresentative of an instantaneous or present error. In the integralportion 171, the control system 18, shown in FIG. 63, calculates theintegral of the signal Error_(ni) over time to provide an output signalrepresentative of the accumulation of past error. The integral portion171 includes a gain factor k₁ that is a leakage factor between 0 and 1that is applied to the integrated Error_(ni) with each time step n toprevent the integral output signal from growing without bound. The gainfactor k₁ may be dependent upon the rate or pressure sampling for thedynamic pressure data. For example, in one exemplary embodiment,provided for mere illustrative purposes, the gain factor k₁ may bebetween 0.93 and 0.99 for a sampling rate of approximately 10 Hz. Theoutput signal from the integral portion 171 is multiplied by a gainfactor k₁ to provide the weighted output signal representative of pasterror. In the derivative portion 172, the control system 18, shown inFIG. 63, calculates the derivative of the signal Error_(ni) bysubtracting the Error_(ni) from the previous time step to provide anoutput signal representative of the rate of change of error, whichadvantageously provides the control system 18, shown in FIG. 63, withfaster response to transients. The output signal from the derivativeportion 172 is multiplied by a gain factor k₁ to provide the weightedoutput signal representative of the rate of change of error. The controlsystem 18, shown in FIG. 63, calculates the error parameter E_(ni) bytaking the weighted sum of the output signals from the proportionalportion 170, the integral portion 171 and the derivative portion 172.The control system 18, shown in FIG. 63, may use this error parameterE_(ni) for calculating the time between pulses Δt for each actuatorchannel i as discussed above.

The control logic discussed above advantageously works in the regimewhere the error parameter E is between and zero (0) and the maximumallowable error E_(max). However, in some situation, the control system18, shown in FIG. 63, may determine that the error parameter E isoutside of that regime. For example, the control system 18, shown inFIG. 63, may determine that the error parameter E exceeds the maximumallowable error E_(min) which would result in the required time betweenpulses Δt to be shorter than the minimum time Δt_(min). Therefore, inthe situation where the error parameter E exceeds the maximum errorE_(min), the control system 18, shown in FIG. 63, turns the pump full onto restore the pressure to the desired setpoint pressure.

In some embodiments, when the control system 18, shown in FIG. 63,implements the control logic discussed above, it is possible that whenΔt comes due and a pulse of air should be supplied to a particularactuator 8024, shown in FIG. 64A, the instantaneous pressure within theactuator 8024, shown in FIG. 64A, may higher than what the pump 8048,shown in FIG. 19B, can reasonably supply due to transient externalloading. Therefore, if the instantaneous pressure is well above thepressure setpoint, the control system 18, shown in FIG. 63, may deferthe air pulse briefly until the instantaneous pressure returns to areasonable level in which the pump 8048, shown in FIG. 19B, may operate.

In some embodiments, when the control system 18, shown in FIG. 63,implements the control logic discussed above, the monitored pressureP_(ni) after passing through the low-pass filter 168 may be above thetarget pressure setpoint for a long period of time. This may cause theoutput signal from the integral portion 171 of the PID controller 169 tobecome large and negative. To compensate for this, the control system18, shown in FIG. 63, may include a predefined large and negativethreshold for the integral portion that, when surpassed by the outputsignal, causes the control system 18, shown in FIG. 63, to provide oneor more brief pulses of venting, by opening one or more valves 8043,shown in FIG. 19C, to reduce the pressure in the actuator 8024, shown inFIG. 64A, to a level below the target setpoint pressure, which, overtime, brings the output signal from the integral portion 171 back towardzero.

It stands to reason that, when the pressure setpoint for a particularchannel is higher, the leakage rate from that channel will be higherthan for the same channel at a lower pressure setpoint. Therefore, theleak compensation mode described above may advantageously compensate forhigher leakage rates by providing uniform pulses of air more frequentlywhen the pressure setpoint for a channel is higher than when thepressure setpoint is lower. Additionally, in some embodiments, thecontrol system 18, shown in FIG. 63, may vary the pulse durationdirectly with the operating pressure. Thus, when in a higher operatingpressure regime, longer pulses may partially or completely compensatefor the higher leakage rates. As should be understood by those skilledin the art, the relationship between setpoint pressure and pulse widthmay be linear, exponential, etc.

In some embodiments of the leak compensation mode, the control system18, shown in FIG. 63, may advantageously utilize statistics to detect aleaky channel. For example, the control system 18, shown in FIG. 63, maykeep track of how many pulses of air are delivered to each channel overa prolonged period of time to determine an average pulse rate for eachchannel. The control system 18, shown in FIG. 63, may then compare thepulse rates to one or more empirically determined pulse rates calculatedbased on a nominal system. If the pulse rate for a channel issignificantly above the pulse rate for the nominal system, the controlsystem 18, shown in FIG. 63, may identify the channel as leaky.Additionally or in the alternative, the control system 18, shown in FIG.63, may compare the averaged pulse rate of one channel to the pulserates of one or more other peer channels to determine whether or not achannel is leaky since, a leaky channel will require a greater number ofpulses compared to its peers over a long period of time to maintain asetpoint pressure.

By implementing the control logic for the leak detection mode asdiscussed above, the control system 18, shown in FIG. 63, is able toadvantageously monitor the pressure in actuators 8024, shown in FIG.64A, and to maintain the baseline pressure or the current pressuresetpoint. The leak compensation mode may, in some embodiments, bereferred to as a closed-loop system, where monitoring, inflating anddeflating may be automatic based on pre-set/pre-determined values, e.g.the baseline pressure, pressure setpoint and/or error threshold.However, in some embodiments, the closed-loop system may be elective bythe user and, thus, the user may instead elect to manuallyinflate/deflate the actuators 8024, shown in FIG. 64A, based, e.g., onrecommendations from the control system 18, shown in FIG. 63, and/orbased on user desires/requirements.

In some embodiments, the user may indicate to the control system 18,shown in FIG. 63, that they are planning either high-intensity orlow-intensity activity, compared with baseline activity. Baselineactivity may be that activity which may be performed comfortably andadequately at the baseline pressure.

Referring to FIG. 69, the user may indicate to the control system 18,shown in FIG. 63, that they are preparing for high-intensity activity(e.g., using a button or navigating through a menu or the like) at 174.The control system may then inflate/increase the pressure setpoint ofone or more actuators 8024, shown in FIG. 64A, e.g. bladders 8028 andstrap actuators 8068, shown in FIG. 64A, at 176 to a high pressuresetting. The high pressure setting, in some embodiments, provides agreater degree of fixation, i.e., more tightly coupling the dynamicsupport apparatus 10, shown in FIG. 63, to the user. This increasedfixation may allow increased usability of the prosthetic device 11,shown in FIG. 63, which may be desired for high-intensity activities,for example, but not limited to, lifting a gallon of milk to a highshelf and/or carrying heavy loads. The user may then indicate to thecontrol system 18, shown in FIG. 63, that the high-intensity activity iscomplete (e.g., using a button or navigating through a menu or the like)at 178. Once the user indicates that high-intensity activity iscomplete, the control system 18, shown in FIG. 63, may decrease theinflation/pressure of one or more actuators 8024, shown in FIG. 64A,e.g. bladders 8028 and strap actuators 8068, shown in FIG. 64A, at 180to return to the baseline pressure.

Referring to FIG. 70, in some embodiments, the user may similarlyindicate to the control system 18, shown in FIG. 63, that they arepreparing for low-intensity activity (e.g., using a button or navigatingthrough a menu or the like) at 182. The control system may thendeflate/decrease the pressure setpoint of one or more actuators 8024,shown in FIG. 64A, e.g. bladders 8028 and strap actuators 8068, shown inFIG. 64A, at 184 to a low pressure setting. Thus, the user is able tocommand the control system 18, shown in FIG. 63, to decrease pressure inthe actuators 8024, shown in FIG. 64A, when the user expects a period oftime where their activity will be low, i.e., the prosthetic device 11,shown in FIG. 63, may be in minimal use. In some embodiments, the lowpressure setting may provide for a relaxed interface fit of the dynamicsupport apparatus 10, shown in FIG. 63, without requiring the user tocompletely doff the dynamic support apparatus 10, shown in FIG. 63. Theuser may then indicate to the control system 18, shown in FIG. 63, thatthe low-intensity activity is complete (e.g., using a button ornavigating through a menu or the like) at 186. Once the user indicatesthat the low-intensity activity is complete, the control system 18,shown in FIG. 63, may increase the inflation/pressure of one or moreactuators 8024, shown in FIG. 64A, e.g. bladders 8028 and strapactuators 8068, shown in FIG. 64A, at 188 to return to the baselinepressure. In some embodiments, the user may transition directly fromlow-activity to high-activity, and vice-versa, by indicating “high”activity while in the low-activity setting, and vice-versa, (e.g., usinga button or navigating through a menu or the like). In theseembodiments, the control system 18, shown in FIG. 63, responds asdiscussed above by inflating the actuators 8024, shown in FIG. 64A, to ahigh pressure setting to prepare for high-activity or by decreasing theactuator pressure to a low pressure setting to prepare for low-activity.

Referring back to FIG. 64A, in some embodiments, the control system 18,shown in FIG. 63, may infer the user's activity level based on the timehistory of operating pressures in the various actuators 8024 (e.g.bladders 8028 and straps 8068) that are being monitored by the controlsystem 18, shown in FIG. 63. When the control system 18, shown in FIG.63, infers that the user is engaged in heavy activity, it mayautomatically increase one or more pressure setpoints of one or moreactuators 8024 to improve the fit of the prosthetic support apparatus8010. Similarly, when the control system 18, shown in FIG. 63, infersthat the user is engaged in low or no activity, it may automaticallydecrease one or more pressure setpoints of one or more actuators 8024 torelax the fit of the prosthetic support apparatus 8010. Thus, thecontrol system 18, shown in FIG. 63, may advantageously permit theprosthetic support apparatus 8010 to engage the user less tightly than aconventional prosthetic support during a majority of time when theprosthesis 11, shown in FIG. 63, is not being actively used, but tightlyengage the user during those times when it is necessary due to increasedactivity.

To infer the user's activity level, in some embodiments, the controlsystem 18, shown in FIG. 63, may determine variability in the operatingpressures in the actuators 8024 using the pressure time history for theactuators 8024. To determine the variability, the control system 18,shown in FIG. 63, may include a high-pass filter (not shown) throughwhich the pressure time history may be processed. Applying a high-passfilter (not shown) to the pressure time history, with a low bandwidth,removes the steady-state (i.e. DC) pressure data and reveals the dynamic(i.e. AC) pressure data in the signal. This dynamic pressure data islargely the result of external loading transients from motion of theprosthesis 11, shown in FIG. 63, and load-carrying, which is indicativeof the user's activity level. For computational efficiency, in someembodiments, the high-pass filter (not shown) may be realized using thelow-pass filter 168, shown in FIG. 68, and discussed above in connectionwith the leak compensation mode. To obtain the dynamic pressure datausing the low-pass filter 168, shown in FIG. 68, the control system 18,shown in FIG. 63 may subtract the low-passed filtered pressure signalfrom the unfiltered pressure signal.

The control system 18, shown in FIG. 63, may take the absolute value ofthis dynamic pressure data and compare it to a reference pressure thatrepresents the pressure variability for the user engaging in a typical,moderate level of activity. When the magnitude of the absolute value ofthe dynamic data is below this reference pressure, the control system18, shown in FIG. 63, infers that the user is engaged in low or noactivity. When the magnitude of the absolute value of the dynamic datais above this reference pressure, the control system 18, shown in FIG.63, infers that the user is active. In some embodiments, the controlsystem 18, shown in FIG. 63, effects the comparison to the referencepressure by calculating a conditioned pressure by subtracting thereference pressure value from the absolute value of the dynamic data.The control system 18, shown in FIG. 63, may then determine whether theresulting conditioned pressure is greater than zero to evaluate whetherthe user is engaged in activity.

In some embodiments, the control system 18, shown in FIG. 63, mayaugment the activity reference pressure with a deadband that definestypical or moderate activity as a range of pressures, rather than just asingle pressure. In these embodiments, the control system 18, shown inFIG. 63, sets the conditioned pressure to zero if it falls within thedeadband range and infers activity only when the conditioned pressure isgreater than zero, i.e. above an upper limit of the deadband range.Likewise, the control system 18, shown in FIG. 63, may infer inactivityonly when the conditioned pressure is less than zero, i.e. below a lowerlimit of the deadband range. The deadband may be symmetric about theactivity reference pressure, asymmetric about the activity referencepressure or may extend only on one side of the activity referencepressure or the other. The deadband advantageously allows the controlsystem 18, shown in FIG. 63, to set a range of dynamic pressure that isconsidered ordinary or expected, with only measurements outside of thedeadband range being considered either as activity or inactivity. Insome embodiments, rather than defining the deadband as existing aboutthe activity reference pressure, the control system 18, shown in FIG.63, may instead simply define the deadband as existing between the ahigh activity reference pressure and a low activity reference pressure.

While the determination of activity or inactivity may be made by thecontrol system 18, shown in FIG. 63, from a single pressure reading, inmost embodiments, the determination is preferably based on a trend ofactivity or inactivity over many pressure readings as observed in time,for example, at time intervals n. To make the determination, the controlsystem 18, shown in FIG. 63, may include an accumulator (not shown) foreach actuator channel i. The control system 18, shown in FIG. 63,increases the accumulator for a given actuator channel i whenever thecontrol system 18, shown in FIG. 63, infers activity for that actuatorchannel i at time interval n, and decreases the accumulator wheneverinactivity is inferred at the time interval n. The control system 18,shown in FIG. 63, calculates a global activity metric by taking anaverage of the accumulators (not shown), across all actuator channels i,which provides a global measure of user activity or inactivity. When theglobal activity metric exceeds some predetermined positive activitythreshold, the control system 18, shown in FIG. 63, concludes that theuser is engaged in activity and has been so for some time. Upon such adetermination, the control system 18, shown in FIG. 63, mayautomatically increase the pressure setpoint of one or more of theactuators 8024 to tighten the fit of the dynamic support apparatus 8010.Conversely, if the global activity metric becomes less than a predefinednegative activity threshold, the control system 18, shown in FIG. 63,concludes that the user has been in a prolonged period of inactivity.Upon such a determination, the control system 18, shown in FIG. 63, mayautomatically decrease one or more of the pressure setpoint(s). Aftermaking a change to one or more of the pressure setpoints, the controlsystem 18, shown in FIG. 63, resets all of the accumulators (not shown)back to zero and restarts the monitoring process.

In some embodiments, rather than only accumulating time spent above andbelow the activity reference, the control system 18, shown in FIG. 83,may instead calculate an activity metric for each actuator channel i byintegrating the conditioned pressure in time. Taking the integral of theconditioned pressure allows the control system 18, shown in FIG. 63, totake into account not only whether the conditioned pressure in eachactuator channel i is positive or negative, but also the extent to whichthe activity metric is above or below the activity reference pressure.Therefore, in these embodiments, large and prolonged excursions from theactivity reference pressure in an actuator channel i are weighted moreheavily than small perturbations in the control system's determinationof activity and/or inactivity. Accordingly, the positive activitythresholds would be crossed much sooner in response to heavy activitythan in embodiments where the control system 18, shown in FIG. 63, onlyaccumulates time spent above and below the activity reference, asdiscussed above. The time integral of the conditioned pressure has aleakage factor k_(leak), which ranges from 0 to 1, applied to it tocontinually force the activity metric towards zero from both thepositive and negative directions. This leakage factor k_(leaqk) will, inessence, provide the accumulated history with a limited memory, andprevent the integral term from growing without bound. The gain factork_(leak) may be dependent upon the rate or pressure sampling for thedynamic pressure data. For example, in one exemplary embodiment,provided for mere illustrative purposes, the gain factor k_(leak) may bebetween 0.93 and 0.99 for a sampling rate of approximately 10 Hz.

In some embodiments, rather than using the single activity metric forthe determination of both activity and inactivity, the control system18, shown in FIG. 63, may divide the determination into two separatemetrics based on whether the conditioned pressure is positive ornegative. For example, a positive conditioned pressure would increasethe activity metric, which would, therefore, be based on the timeintegral of only positive conditioned pressures. A negative conditionedpressure would, instead, be used to increase an inactivity metric basedon the time integral of only negative conditioned pressures. In theseembodiments, the gain factor k_(leak) may be applied to both theactivity metric and the inactivity metric.

The control system 18, shown in FIG. 63, may calculate the globalactivity metric by taking an average of the activity metrics, across allactuator channels i, to provide the global measure of user activity.Similarly, the control system 18, shown in FIG. 63, may calculate aglobal inactivity metric by taking an average of the inactivity metrics,across all actuator channels i, to provide the global measure ofinactivity. In a manner similar to that discussed above, the controlsystem 18, shown in FIG. 63, may conclude that the user is engaged insustained activity when the global activity metric exceeds somepredetermined activity threshold. Upon such a determination, the controlsystem 18, shown in FIG. 63, may automatically increase the pressuresetpoint of one or more of the actuators 8024 to tighten the fit of thedynamic support apparatus 8010. Similarly, the control system 18, shownin FIG. 63, may conclude that the user has been in a prolonged period ofinactivity if the global inactivity metric passes some predefinedinactivity threshold. Upon such a determination, the control system 18,shown in FIG. 63, may automatically decrease one or more of the pressuresetpoint(s).

Splitting the global activity metric into separate global activity andinactivity metrics allows the control system 18, shown in FIG. 63, to bemore responsive to user activity than with the single global activitymetric. For example, with only the single global activity metric, aprolonged period of inactivity that does not exceed the inactivitythreshold must be overcome by user activity to first bring the globalactivity metric back from a large and negative value, through zero, andon up to the activity threshold in order for activity to be detected.With the separate activity and inactivity metrics, during a prolongedperiod of inactivity, the activity metric will be clamped at zero. Thus,if a user then begins a period of heavy activity, the activity thresholdwill be crossed much sooner because the activity metric may begin togrow immediately independently of how long the user engaged in activity,thereby providing for improved activity detection. Simultaneously, theinactivity metric may advantageously be decayed back toward zero. Thus,separate activity and inactivity metrics advantageously allow thecontrol system 18, shown in FIG. 63, to be programmed to require aconcerted and sustained period of activity or inactivity to reach eitherthreshold for changing the inflation pressure setpoint. Additionally,the split activity and inactivity metrics allow the control system 18,shown in FIG. 63, to be tuned to be more immune to pressureperturbations caused by pulse density modulation, discussed above, whichappear to the control system 18, shown in FIG. 63, as user activity inthe dynamic pressure data.

Referring back to FIG. 63, in other embodiments, the control system 18may estimate user activity directly from information obtained from theprosthesis 11. For example, using its own sensors (not shown), theprosthesis 11 can estimate the load being applied to one or more of itsjoints.

In some embodiments, a load cell (not shown) installed at an interfacebetween the dynamic support apparatus 10 and the prosthesis 11 maymeasure an aggregate load that is being transferred from the prosthesis11 to the residual anatomy 12 through the dynamic support apparatus 10.The control system 18 may estimate user activity, at least in part, uponthe measured aggregate load. For example, the aggregate loadmeasurements may be transmitted to the control system 18, e.g. throughwireless data transmission, and the control system 18 may analyze thatdata to infer the user's activity level. In some embodiments, thecontrol system 18 may calculate the time-derivative of the forces,wherein a large time-derivative of force indicates a load that israpidly changing and a small time-derivative of force indicates a loadthat is not changing. The control system 18 may process this informationin a manner similar to the pressure time history, as described above, toproduce either a single global activity metric or split activity andinactivity metrics, as discussed above. These metrics may be used by thecontrol system 18 in substantially the same manner as the pressure-basedmetrics discussed above to determine whether to increase or decrease oneor more pressure setpoints.

Although described separately for simplicity, in some embodiments, thepressure-based activity and inactivity metrics from each actuatorchannel i may be combined with the metrics produced from load dataobtained from the prosthesis 11 and/or from measurement of the aggregateloading at the interface between the prosthesis 11 and the dynamicsupport apparatus 10. For instance, in some embodiments, the metrics maybe combined as a weighted sum, and the combined result used indetermining whether to increase or decrease one or more pressuresetpoints.

In some embodiments, the control system 18 may have one or more biasingmechanisms to ensure that, having made a change to one or more pressuresetpoints in one direction (e.g. increasing or decreasing), the nextchange in that same direction is less likely. The one or more biasingmechanisms ensure that a small twitch while at a low inflation setting,which the control system 18 may characterize as high activity, does notquickly result in the dynamic support apparatus 10 being inflated to itsmaximum amount.

In some embodiments, as the biasing mechanism, the control system 18 mayadjust the activity reference pressure directly with pressure setpoint.For example, when the dynamic support apparatus 10 is at a highinflation state, it should be because the user is engaged in higheractivity, such as carrying a heavier load. In such a situation, onewould expect a greater dynamic pressure content commensurate with thathigher activity. Therefore, when the dynamic support apparatus 10 is ata high inflation state, the control system 18 may increase the activityreference pressure, since the activity reference pressure is a measureof what is a typical activity level. Thus, the control system 18 may usethe biasing mechanism to discount the activity that is detected when athigher pressures, while simultaneously making inactivity morepronounced. Similarly, when the dynamic support apparatus 10 is at a lowinflation state, the biasing mechanism will tend to amplify the effectof even moderate activity. The biasing mechanism may provide a linearrelationship between the activity reference pressure and the inflationstate or may provide some other desired relationship.

In some embodiments, the control system 18 may change the activitythreshold and inactivity threshold with pressure setpoint as the biasingmechanism. In these embodiments, the control system 18 will typicallyadjust the activity and inactivity thresholds in concert, i.e. bothraising or lowering together, though not necessarily by the samemagnitude. For instance, when the dynamic support apparatus 10 is at ahigh inflation state, the activity threshold may be much higher thanwhen the dynamic support apparatus 10 is at a low inflation state. Theseparation between the activity and inactivity thresholds may beconstant across the whole inflation range or, in some embodiments, maybe varied by the control system 18. This biasing mechanism may alsoprovide a linear relationship between the activity and inactivitythresholds and the inflation state or may provide some other desiredrelationship. Thus, the control system 18 is able to advantageouslyalter the size of the deadband range within which dynamic pressurechanges are considered normal activity. For example, in one illustrativeembodiment, the deadband range may narrow and approach zero at a lowinflation state, but may rise and broaden at higher inflation levels.

In some embodiments, the control system 18 may alter the deadbandapplied in determining the activity and inactivity metrics as thebiasing mechanism. For example, at a low inflation state, the controlsystem 18 may reduce the upper deadband threshold and may increase thelower deadband threshold. Conversely, at a high inflation state, thecontrol system 18 may increase the upper deadband threshold, whilereducing the lower deadband threshold. The total width of the deadbandrange may be constant across the whole inflation range, or may be variedby the control system 18. Although these biasing mechanisms have beendescribed separately for simplicity, those knowledgeable in the artshould recognize that the biasing mechanism could also be anycombination of those discussed above.

Thus, the control system 18 may advantageously automatically adjust toan appropriate pressure setting for a current level of activity and maymaintain that pressure setting until a change in the level of activityis detected. Additionally, by detecting inactivity in addition toactivity, the pressure setpoints may be reduced by a pre-determinedamount after a period of inactivity so that the control system 18 has atendency to minimize the amount of pressure applied by the dynamicsupport apparatus 10 to the user, thereby improving user comfort andpreventing adverse affects to the user's tissue contacted by the dynamicsupport apparatus 10.

Referring to FIG. 71, in some embodiments, the control system 18, shownin FIG. 63, may also include an auto-relief system in the leakcompensation mode to ensure the one or more actuators 8024, shown inFIG. 64A, e.g. bladders/straps, are not at a high pressure for so long atime that the user's tissue may be adversely affected, for example,where the user's tissue may experience inadequate blood supply orcirculation to a local region secondary to blockage of blood vessels tothat region. Thus, at 198, the control system 18, shown in FIG. 63,monitors the pressure in one or more actuators 8024, shown in FIG. 64A,as discussed above. The control system 18, shown in FIG. 63, thenevaluates whether the monitored pressure exceeds a pre-determined safetythreshold at 200. In some embodiments, the safety threshold may be afunction of time and pressure, for example, by comparing an integral ofthe monitored pressure to the safety threshold, thereby accounting forboth the magnitude of and duration at an elevated pressure. If thecontrol system 18, shown in FIG. 63, determines that the monitoredpressure of one or more actuators 8024, shown in FIG. 64A (e.g.bladders/straps) exceeds the safety threshold at 200 (e.g. in somecombination of magnitude and duration), that actuator 8024, shown inFIG. 64A, is identified by the control system 18, shown in FIG. 63, andthe control system 18, shown in FIG. 63, automatically starts anauto-relief mode at 202 to alleviate the pressure on the tissue.

For example, where any one or more bladders 8028, shown in FIG. 64A,and/or straps 8068, shown in FIG. 64A, has been maintained at ahigh-pressure for a long period of time (e.g., longer than a pre-setperiod of time that may be considered acceptable for user health), thisbladder 8028, shown in FIG. 64A, and/or strap 8068, shown in FIG. 64A,may be determined to have exceeded the safety threshold by the controlsystem 18, shown in FIG. 63. The control system 18, shown in FIG. 63,may then enter into the auto-relief mode at 202 for a pre-determinedamount of time. In the auto-relief mode, the control system 18, shown inFIG. 63, may vent the identified bladder 8028, shown in FIG. 64A, and/orstrap 8068, shown in FIG. 64A, to a lower pressure for a pre-determinedamount of time followed by partial re-inflation of the identifiedbladder 8028, shown in FIG. 64A, and/or strap 8068, shown in FIG. 64A,for a pre-determined amount of time which may, in some embodiments,encourage perfusion of the user's tissue.

Once the control system 18, shown in FIG. 63, determines that theauto-relief criteria has been met at 204, the control system 18, shownin FIG. 63, may return the bladder 8028, shown in FIG. 64A, and/or strap8068, shown in FIG. 64A, to the pressure/inflation level at which it wasbefore the auto-relief mode was initiated. In some embodiments, thecontrol system 18, shown in FIG. 63, may limit the auto-relief mode toone bladder 8028, shown in FIG. 64A, and/or strap 8068, shown in FIG.64A, at any one time. This may advantageously maintain stability of thedynamic support apparatus 10, shown in FIG. 63, so that the user maycontinue regular activity during the auto-relief mode with minimumnegative effect.

Although the auto-inflate/auto-deflate and auto-relief systems have beendescribed separately herein for simplicity, it should be understood bythose skilled in the art that the auto-inflate/auto-deflate system andthe auto-relief system, as well as other control systems, may becombined and integrated into the leak compensation mode discussed abovefor improved functionality.

In some embodiments, the control system 18 for the dynamic supportsystem 142, shown in FIG. 63, may be configured using a softwareapplication through, for example, a personal computer. In someembodiments, using this software application, the number and types ofactuators 8024, shown in FIG. 64A, may be configured along with theiroperating pressures. The software application may be, in someembodiments, used to configure user inputs, for example, whetherintegral to the control unit 8052, or remote, for controlling operationof one or more features of the dynamic support system 142, shown in FIG.63. System faults may also be diagnosed through the softwareapplication. In some embodiments, the software application may be usedby prosthetists as part of the fitting process for the dynamic supportapparatus 10, shown in FIG. 63. In some embodiments, the softwareapplication, or another software application, may be used by the user toupdate the settings of the dynamic support system 142, shown in FIG. 63,and to reprogram/re-assign the user inputs to the elected functionality.

In some embodiments, the user may indicate to the control system 18,shown in FIG. 63, for example, in some embodiments, by pressing a buttonor otherwise navigating through a menu using the control unit 8052,shown in FIG. 64A, that the user is preparing to doff the dynamicsupport apparatus 10, shown in FIG. 63. In some embodiments, the controlsystem 18, shown in FIG. 63, may then deflate/eliminate pressures fromthe bladders 8028, shown in FIG. 64A and/or straps 8068, shown in FIG.64A. The reduced fixation from deflating the bladders 8028, shown inFIG. 64A and straps 8068, shown in FIG. 64A, increases the ease withwhich the user may doff the dynamic support apparatus 10, shown in FIG.63. In some embodiments, following doffing, the user may attach thecontrol unit 8052, shown in FIG. 64A, to a charger or may otherwisecharge the control unit 8052, shown in FIG. 64A, using wireless chargingand/or replacing the batteries/power source.

Referring to FIG. 72, according to some embodiments, a donning stand 206may be provided to facilitate donning and doffing of the dynamic supportapparatus 10, shown in FIG. 63, with the prosthetic device 11, shown inFIG. 63, attached thereto. The donning tree 206 includes a verticaltower 208 with a base 210 at its lower end for contacting an underlyingsurface and for supporting the vertical tower 208 in an uprightposition. The vertical tower 208 has a substantially horizontal armsupport 212 adjustably coupled thereto such that a height of the armsupport 212 from the base 210 may be adjusted by moving the arm support212 along at least a portion of a length of the vertical tower 208. Oncea desired height is reached, the arm support 212 may be locking inposition by a securing mechanism (not shown). The vertical tower 208also includes a recharging tray 214 coupled thereto for supporting andcharging one or more batteries of the control system 18, shown in FIG.63, of the dynamic support apparatus 10, shown in FIG. 63, and/or of theprosthetic device 11, shown in FIG. 63. The recharging tray 214 mayinclude one or more charging outlets (not shown) or may include awireless charging pad for charging one or more batteries simultaneously.The arm support 212 includes an elbow yoke 216 at its end proximate thevertical tower 208 and a handle 218 at its distal end. The elbow yoke216 is configured to accommodate an elbow (not shown) of the prostheticdevice 11, shown in FIG. 63, and, in some embodiments, may be configuredto accommodate the elbow (not shown) in a particular configuration, suchas an elbow actuated to approximately 90 degrees of flexion. The handle218 is positioned such that, when the prosthetic elbow (not shown) ispositioned in the elbow yoke 216, a prosthetic hand (not shown) of theprosthetic device 11, shown in FIG. 63, may wrap naturally around thehandle and grip it.

In operation, the height of the arm support 212 of the donning stand 206may advantageously be adjusted to accommodate a particular user. Onceadjusted to the desired height, the user may doff the prosthetic arm 11,shown in FIG. 63, and the dynamic support apparatus 10, shown in FIG.63, on the donning stand 206 by positioning the prosthetic elbow (notshown) in the elbow yoke 216 and gripping the prosthetic hand (notshown) to the handle 218. The user may then remove the dynamic supportapparatus 8010, shown in FIG. 64A, which is supported by the donningstand 206 through the prosthetic device 11, shown in FIG. 63. The usermay also store accessories, such as the control unit 8052, shown in FIG.64A, of the dynamic support 8010, shown in FIG. 64A, on the rechargingtray 214 to recharge said accessories. Thus, advantageously, if the useremploys the donning stand 206 for supporting the prosthetic device 11,shown in FIG. 63, and the dynamic support apparatus 10, shown in FIG.63, overnight, the prosthetic device 11, shown in FIG. 63, and thedynamic support apparatus 10, shown in FIG. 63, remain pre-positioned onthe donning stand 206 for optimal donning in the morning. Additionally,the recharging tray 214 will recharge the batteries of the prostheticdevice 11, shown in FIG. 63, and the dynamic support apparatus 10, shownin FIG. 63, so that each are ready for use the next morning.

The dynamic support apparatus is advantageous for many reasons,including, but not limited to, because it is able to compensate forshape changes of the residuum and/or loading from a prosthetic device byactuating the actuators. Additionally, when the actuators actuate,compliant tissue surrounding the bone within the residuum is displaced,thereby minimizing the amount of soft compliant tissue between thedynamic support apparatus and the bone within the residuum. Thisadvantageously provides for a more stable and responsive interfacebetween the dynamic support apparatus and the residuum. The dynamicsupport apparatus is also advantageous because various actuators may beactuated and unactuated at different times to improve blood flow withinthe residuum, without losing the overall stability of the dynamicsupport apparatus.

It should be understood that the various embodiments described hereinare examples and that other embodiments are contemplated. Also, valuesgiven in the various examples serve as one example and the varioussystems and methods described herein are not limited to the valuesgiven. Further, in use, various methods and systems may vary based onthe user.

The dynamic support apparatus is also able to advantageously detect thepressure and/or force provided by each actuator and to compensate forchanges in the detected pressure and/or force. Thus, the dynamic supportapparatus is able to self-compensate for pressure and/or force changesto provide increased securing forces and tighten the dynamic supportapparatus only when necessary and to loosen the dynamic supportapparatus when the prosthetic device is under lower load. This minimizesthe perceived weight of the prosthetic device, which may allow the userto adorn the prosthetic device and dynamic support apparatus for agreater time than with a conventional prosthesis.

Although the dynamic support apparatus is illustrated for use with anupper-limb prosthesis, the support apparatus is adaptable to other bodyappliances such as ski boots, shoes, backpacks, helmets, lower-limbprostheses, braces worn around a body part, or anything designed to beworn around a body part.

While the principles of the invention have been described herein, it isto be understood by those skilled in the art that this description ismade only by way of example and not as a limitation as to the scope ofthe invention. Other embodiments are contemplated within the scope ofthe present invention in addition to the exemplary embodiments shown anddescribed herein. Modifications and substitutions by one of ordinaryskill in the art are considered to be within the scope of the presentinvention.

What is claimed is:
 1. A control unit for a dynamic support apparatushaving at least one actuator, the control unit comprising: a pumpconnected to the at least one actuator for causing actuation thereof; asensor configured to detect a pressure of the at least one actuator; anda control system configured to control the pump, the control system incommunication with the sensor and configured to receive a signalindicative of the pressure of the at least one actuator therefrom, thecontrol system including a plurality of predefined modes, eachpredefined mode including an activity reference pressure indicative of apredetermined activity; wherein the control system is configured tocontrol the pump to actuate the at least one actuator at least inresponse to the pressure detected by the sensor and to evaluate a useractivity level based at least on the signal from the sensor indicativeof the pressure of the at least one actuator; and wherein the evaluationof the user activity level is made with respect to the activityreference pressure indicative of the predetermined activity of acurrently selected predefined mode of the plurality of predefined modes.2. The control unit according to claim 1, additionally comprising adetachable manifold fluidly coupling the at least one actuator to thepump through an interior channel.
 3. The control unit according to claim2, wherein the detachable manifold fluidly couples a plurality ofactuators to the pump through a plurality of interior channels.
 4. Thecontrol unit according to claim 3, additionally comprising a valve influid communication with each interior channel for controlling flowtherethrough.
 5. The control unit according to claim 4, wherein controlsystem controls activation of the valves.
 6. The control unit accordingto claim 1, wherein the control system commands the pump to increase thepressure of the at least one actuator if the pressure detected by thesensor drops below a current pressure setpoint by more than a prescribeddeadband.
 7. The control unit according to claim 6, wherein the controlsystem commands venting of the at least one actuator if the pressuredetected by the sensor exceeds the current pressure setpoint by morethan the prescribed deadband.
 8. The control unit according to claim 6,wherein the control system commands the pump at a fixed time interval.9. The control unit according to claim 1, wherein the evaluation of theuser activity level is based on a pressure variability as determined bya high-pass filter.
 10. The control unit according to claim 9, whereinthe evaluation of the user activity level is also based on a timeintegral of said pressure variability.
 11. The control unit according toclaim 1, wherein the control system varies the activity referencepressure directly with a pressure setpoint of the at least one actuator.12. The control unit according to claim 1, wherein the activityreference pressure includes a deadband comprising a range of pressuresindicative of typical the predetermined activity.
 13. The control unitaccording to claim 12, wherein the control system varies an upperreference pressure and a lower reference pressure of the deadbanddirectly with a pressure setpoint of the at least one actuator.
 14. Thecontrol unit according to claim 1, wherein the control system evaluatesthe user activity level based on at least data representing loadingobtained from at least one sensor incorporated into a prosthetic devicesupported by the dynamic support apparatus.
 15. The control unitaccording to claim 1, wherein the dynamic support apparatus includes atleast one sensor for measuring loading at an interface between saiddynamic support apparatus and a prosthetic device supported by thedynamic support apparatus.
 16. The control unit according to claim 15,wherein the control system evaluates the user activity level based on atleast loading measured by the at least one sensor at the interfacebetween said dynamic support apparatus and the prosthetic device. 17.The control unit according to claim 1, wherein the control system isconfigured to control the pump to increase the pressure of the at leastone actuator if a high activity threshold is exceeded.
 18. The controlunit according to claim 17, wherein the control system varies the highactivity threshold directly with a pressure setpoint of the at least oneactuator.
 19. The control unit according to claim 1, additionallycomprising a valve controlled by the control system and in fluidcommunication with the at least one actuator; wherein the control systemis configured to control the valve to decrease the pressure of the atleast one actuator if a low activity threshold is exceeded.
 20. Thecontrol unit according to claim 19, wherein the control system variesthe low activity threshold directly with a pressure setpoint of the atleast one actuator.
 21. The control unit according to claim 1, whereinthe control system evaluates whether a safety threshold has beenexceeded based at least on the signal from the sensor indicative of thepressure of the at least one actuator.
 22. The control unit according toclaim 21, wherein the evaluation of whether the safety threshold hasbeen exceeded is also based on a pressure duration.
 23. The control unitaccording to claim 21, wherein the control system enters an auto-reliefmode if the safety threshold has been exceeded.